Implantable device and delivery system for reshaping a heart valve annulus

ABSTRACT

Systems, devices and methods related to various heart valve implants and for delivery of those implants are described. The implants may be used to re-size a native valve annulus or to replace a native heart valve. The implants include a re-sizable frame having angled struts. The implant is secured to tissue with anchors that can rotate without axial advancement to engage tissue while drawing the implant closer to the tissue. Collars are used to decrease the angle between struts of a frame to contract the implant. The implants can include a rotatable shaft, such as a threaded shaft, located internally to an axially translatable collar. Rotation of the shaft transmits force to the collar to cause the collar to translate axially, closing the angle of adjacent struts and decreasing the width of the implant and thus of the annulus. The implants can be delivered, secured and contracted via a catheter. The implants are repositionable and retrievable via catheter.

INCORPORATION BY REFERENCE TO ANY RELATED APPLICATIONS

Any and all applications for which a foreign or domestic priority claimis identified in the Application Data Sheet as filed with the presentapplication are hereby incorporated by reference in their entirety under37 CFR 1.57.

This application is a continuation of U.S. patent application Ser. No.15/893,122, filed Feb. 9, 2018, which claims the benefit of priority toU.S. provisional patent application No. 62/457,441, entitled IMPLANTABLEDEVICE AND DELIVERY SYSTEM FOR RESHAPING A HEART VALVE ANNULUS and filedFeb. 10, 2017, and to U.S. provisional patent application No.62/552,896, entitled IMPLANTABLE DEVICE AND DELIVERY SYSTEM FORRESHAPING A HEART VALVE ANNULUS and filed Aug. 31, 2017, the disclosureof each which is hereby incorporated by reference herein in its entiretyfor all purposes and forms a part of this specification.

BACKGROUND Field

In general, features related to implantable medical devices aredescribed. In particular, devices for reshaping a valve annulus andassociated transcatheter delivery and positioning systems for implantingthe various devices are described.

Description of the Related Art

Heart valve incompetency is a serious problem. For example, heartdisease can cause the chambers of the heart to expand and weaken. Withspecific reference to the mitral valve, as a result of aging or disease,the left ventricle dilates and the papillary muscles are displaced.Consequently, the annulus of the mitral heart valve dilates excessively.In this state of dilation, valve leaflets no longer effectively close,or coapt, during systolic contraction. Consequently, regurgitation (i.e.retrograde flow back across the valve that should be closed) of bloodoccurs during ventricular contraction. Cardiac output is thus decreased.

This condition is typically addressed by the surgical implantation of anannuloplasty ring. A surgeon positions the annuloplasty ring proximatethe valve annulus and sutures it in place thereby restoring the valveannulus to approximately its native configuration. The valve leafletscan now function normally again.

This procedure is invasive as it is performed open chest and is alsotime consuming. In open heart surgery, the patient is put oncardiopulmonary bypass with its associated risks of morbidity andmortality due to stroke, thrombosis, heart attack and extended recoverytime.

There is, therefore, a need for less invasive and more efficientsolutions to these problems that avoid the aforementioned drawbacks.

SUMMARY

The embodiments disclosed herein each have several aspects no single oneof which is solely responsible for the disclosure's desirableattributes. Without limiting the scope of this disclosure, its moreprominent features will now be briefly discussed. After considering thisdiscussion, and particularly after reading the section entitled“Detailed Description,” one will understand how the features of theembodiments described herein provide advantages over existing systems,devices and methods.

The following disclosure describes non-limiting examples of someembodiments. For instance, other embodiments of the disclosed systemsand methods may or may not include the features described herein.Moreover, disclosed advantages and benefits can apply only to certainembodiments of the invention and should not be used to limit thedisclosure.

Systems, devices and methods for a heart valve implant and relateddelivery systems are described. The implant is intended to be deliveredin a minimally invasive percutaneous manner, such as transfemorally,transeptally, or transapically. The implant may instead be implantedsurgically, in that it should reduce the duration of the procedure and,more particularly, the duration that the patient is on bypass. Thedevelopment can be directed to mitral valve or tricuspid valveprocedures.

The development relates to the implant and delivery systems, andassociated methods of use of each. The implant contracts to a firstconfiguration, such as a delivery configuration, having a first diameterfor delivery via a delivery catheter. The implant is capable ofexpanding out to a second configuration, such as a tissue engagingconfiguration (and/or anchored configuration), having a second diameterlarger than the first diameter to match the shape, e.g. width, of adilated annulus of a heart valve. The implant engages the tissue of theheart valve annulus with anchors and then contracts to a thirdconfiguration, such as an annulus remodeling diameter, having a thirddiameter that is smaller than the second diameter, thus gathering andcinching in the dilated annulus to decrease the width of the dilatedannulus.

The implant includes a tubular frame with moveable struts, where pairsof adjacent struts form proximal apices or crowns and define an anglebetween each pair of adjacent struts. The apices each have a moveablerestraint, for example a slider or collar, at least partiallysurrounding a corresponding pair of adjacent struts. A threaded shaftmechanically communicates with each moveable restraint. After engagingheart valve annulus tissue with the implant, such as with any of thevarious the anchors described herein, the collars can be moved in agenerally axial direction, e.g. downward or distally, along the apexand/or struts, by rotating the threaded shaft. The shaft may extendthrough an opening in the collar such that rotation of the shaft causestranslation of the collar. The shaft may be rotatable about a localcentral axis and be axially stationary relative to a respective apex.The collar may be rotationally stationary and axially moveable relativeto the respective apex. The collar may be moved distally to decrease theangle between the adjacent struts, causing the tubular frame to contractin width. This pulls the tissue of the heart valve annulus closertogether. The implant thus reconfigures the valve annulus down to asmaller width or diameter, reducing and/or eliminating problemsassociated with the valve, such as regurgitation or backflow of blood.For adjustment, the collars can be moved upward or proximally toincrease the angle between the adjacent struts, causing or allowing theframe to expand. The collars are independently moveable to adjustindividual pairs of struts for localized geometric control orrepositioning of the implant. The implant may be retrieved bydisengaging the anchors from the tissue and contracting the implant to asufficiently small width for transcatheter removal from the patient.

A delivery system and associated methods are also disclosed thatcomprise a catheter and imaging and positioning features to maneuver thedistal end of the catheter and the device into the desired positionabove and proximate the heart valve annulus. Transeptal delivery may beused, for example, with procedures involving the mitral valve. Thedelivery system can be used with the implant described herein as well asother implantable devices.

Moreover, the development also provides an artificial heart valve with amodified ring-like structure that not only provides for reduction of theheart valve annulus, but also displaces or replaces one or moredefective heart valve leaflets. The artificial valve may include thevarious implant devices described herein having the one or more leafletsattached thereto.

Also described are distal anchoring features. The anchors may be helicalanchors engaged with openings in distal apexes of the implant. Theanchors may be part of anchor assemblies that include the anchor havinga helical distal portion and a proximal head where the anchor isreceived in an anchor housing or mount at the distal apex. These andother anchoring features, among other advantages, address reliability ofthe distal ends of the ring-like implant frame to secure with and tofully contact the target annulus tissue after the anchors have beenadvanced. This contact may affect the effectiveness of the ring-likemember to appropriately reduce the size of the dilated annulus. Inaddition, such contact ensures that more than only a portion of theanchor embeds into the heart tissue, which among other advantages willprevent pull out during the step of re-sizing the valve annulus.Moreover, for example, with the distal end(s) in contact with the valvetissue, the risk of fatigue failure of the anchor is decreased.

Thus, some embodiments of the anchor assembly described herein aredesigned to achieve more complete contact of the distal ends of theprosthesis with the tissue of the valve annulus and reduce, if noteliminate, gaps between the lower ends of the ring-like member and thevalve tissue. Such contact, among other things, allows the ring-likemember to effectively and appropriately re-size the dilated annulus,reduces the possibility of anchor withdrawal during re-sizing, andreduces the risk of fatigue on the anchors, among other benefits. Theseare merely some of the features described herein.

In one aspect, an implant for reshaping a mitral valve annulus isdescribed. The implant comprises a tubular frame, a shaft and a collar.The tubular frame has a proximal end, a distal end and a central lumenextending therethrough. The frame has a first pair of adjacent strutsjoined at a proximal apex. The shaft is carried by the proximal apex andhas an outer thread. The shaft is configured to rotate about a rotationaxis. The collar is carried by the frame and at least partiallysurrounds the first pair of adjacent struts. The collar has an innerthread engaged with the outer thread of the shaft. Rotation of the shaftabout the rotation axis causes the collar to advance along the firstpair of adjacent struts to change an angle between the first pair ofadjacent struts.

Various embodiments of the various aspects are also described. Forexample, rotation of the shaft about the rotation axis in a firstdirection may cause the collar to advance along the first pair ofadjacent struts toward the distal end to decrease the angle between thefirst pair of adjacent struts, thereby contracting the implant. Rotationof the shaft about the rotation axis in a second direction that isopposite the first direction may cause the collar to advance along thefirst pair of adjacent struts toward the proximal end to allow anincrease in the angle between the first pair of adjacent struts, therebyallowing the implant to expand. The frame further may comprise a firstsupport and a second support extending from the proximal apex toward theproximal end of the frame and at least partially defining a windowconfigured to at least partially retain the shaft therein. The collarmay further comprise a first channel and a second channel configured toreceive respectively the first support and the second support. Theimplant may further comprise a coupling attached to a proximal end ofthe shaft, the coupling configured to be rotated by a driver to rotatethe shaft. The tubular frame may define a central longitudinal axis, andthe adjacent pair of struts may be configured to incline radiallyoutward relative to the central longitudinal axis. The pair of adjacentstruts may be configured to incline radially outward relative to thecentral longitudinal axis in response to decreasing the angle betweenthe first pair of adjacent struts.

The implant may further comprise an anchor coupled with the frame, theanchor configured to engage tissue of the mitral valve annulus. Theframe may further comprise a second pair of adjacent struts joined at adistal apex, with the anchor coupled with the distal apex. The anchormay be a helical anchor. The distal apex may include a series ofopenings configured to rotatably receive the anchor therethrough.

The frame may comprise a second pair of adjacent struts joined at adistal apex, with the distal apex including an anchor housing configuredto rotatably receive the anchor therethrough. The housing may have anopening extending axially therethrough, and the anchor may be configuredto engage the tissue of the heart valve annulus by rotating within thehousing while maintaining an axial position relative to the housing. Theopening may have a proximal engagement structure and a distal chamber,with a maximum width of the distal chamber being greater than a minimumwidth of the proximal engagement structure.

The implant may further comprise a plurality of the first pair ofadjacent struts, with each pair joined at a respective proximal apex, aplurality of the shafts each carried by the respective proximal apex,and a plurality of the collars each configured to engage a respectiveshaft. There may be eight pairs of adjacent struts, eight proximalapices, eight shafts, and eight collars. There may be eight anchors.

In another aspect, an implant for reshaping a mitral valve annulus isdescribed. The implant comprises a tubular frame, a rotatable shaft anda collar. The tubular frame has a first pair of adjacent struts joinedat a proximal apex. The rotatable shaft is located at the proximal apex.The collar at least partially surrounds the first pair of adjacentstruts and the shaft. Rotation of the rotatable shaft causes the collarto advance along the first pair of adjacent struts to decrease an anglebetween the first pair of adjacent struts, thereby contracting theimplant.

Various embodiments of the various aspects are also described. Forexample, the implant may further comprise an anchor coupled with theframe, the anchor configured to engage tissue of the mitral valveannulus. The implant may further comprise a window at the proximal apexthat axially restrains the rotatable shaft.

In another aspect, a method of reshaping a mitral valve annulus isdescribed. The method comprises positioning an implant adjacent a mitralvalve annulus. The implant comprises a tubular frame having a pair ofstruts, a rotatable shaft carried by the frame, a translatable collarengaged with the rotatable shaft and at least partially surrounding thepair of struts, and an anchor coupled with the frame. The method furthercomprises securing the anchor to tissue of the mitral valve annulus,rotating the shaft to cause the collar to translate along the first pairof struts, and decreasing an angle between the first pair of struts dueto translation of the collar.

In another aspect, an implant for reshaping a heart valve annulus havinga “reach anchor” is described. The implant comprises a tubular frame, ahousing and an anchor. The tubular frame has a proximal end, a distalend and a central lumen extending therethrough. The housing is coupledwith the distal end of the frame. The housing has a proximal portion, adistal portion and an opening extending axially therethrough. The anchoris received in the opening of the housing. The anchor is configured toadvance distally to engage tissue of the heart valve annulus by rotatingwithin the housing while maintaining an axial position relative to thehousing. In some embodiments, the anchor is configured to advancedistally to engage tissue of the heart valve annulus by rotating withinthe housing while maintaining a constant or substantially constant axialposition relative to the housing. In some embodiments, the housingfurther comprises an inner threaded portion in the proximal portion, anda chamber in the distal portion, and the anchor is configured to rotatewithin the chamber in the distal portion of the housing whilemaintaining an axial position relative to the distal portion of thehousing. In some embodiments, the anchor further comprises a proximalcylindrical head having a coupling configured to be engaged by a driverto rotate the anchor, and a distal helical portion coupled with theproximal head extending distally therefrom and configured to engage thetissue.

In another aspect, an anchor assembly for an implant for reshaping amitral valve annulus is described. The anchor assembly comprises ahousing and an anchor. The housing has a proximal portion, a distalportion and an opening extending axially therethrough. The anchor isreceived in the opening of the housing. The anchor is configured toadvance distally to engage tissue of the heart valve annulus by rotatingwithin the housing while maintaining an axial position relative to thehousing. In some embodiments, the opening has a proximal engagementstructure and a distal chamber, with a maximum width of the distalchamber being greater than a minimum width of the proximal engagementstructure, and the anchor is configured to rotate within the distalchamber while maintaining an axial position relative to the distalchamber. In some embodiments, the proximal engagement structurecomprises a helical groove.

In another aspect, a method of securing an implant to a heart valveannulus is described. The implant comprises an anchor and an anchorhousing. The method comprises simultaneously i) rotating the anchorwithin the housing, ii) advancing the anchor distally and axially intotissue of the heart valve annulus, and iii) maintaining an axialposition of the anchor relative to the housing.

In another aspect, an implant for reshaping a mitral valve annulushaving flared aspects is described. The implant comprises a tubularframe having a proximal end, a distal end and a central lumen extendingtherethrough. The frame comprises a pair of adjacent struts joined at anapex. The adjacent pair of struts are configured to incline radiallyoutward relative to a central longitudinal axis in response to changingan angle between the pair of adjacent struts.

In another aspect, a coupling for an implant for reshaping a heart valveannulus is described. The coupling comprises a distal base coupled witha proximal lateral projection by a recess surface, with the recesssurface defining an opening between the distal base and the proximallateral projection, and with the opening configured to receive therein arotatable driver for rotating the coupling.

In another aspect, a restraint for an implant for reshaping a heartvalve annulus is described. The implant comprises a pair of adjacentstruts joined at an apex and defining an angle therebetween. Therestraint comprises a body extending axially, a central openingextending axially through the body, and an internal engagement structureon an inner surface of the central opening. The restraint is configuredto at least partially surround the pair of adjacent struts at the apexand to engage the internal engagement structure with an actuator suchthat actuation of the actuator advances the restraint along the pair ofadjacent struts to change the angle therebetween. In some embodiments,the restraint further comprises a first and second channel extendingaxially through the body on either side of the central opening, with thefirst and second channels configured to receive respective supports ofthe implant therethrough.

In another aspect, a rotatable shaft for an implant for reshaping aheart valve annulus is described. The implant comprises a pair ofadjacent struts joined at an apex and defining an angle therebetween.The rotatable shaft comprises an elongated body having an externalthread along an outer surface of the body, and a proximal couplinghaving a distal base coupled with a proximal lateral projection by arecess surface, with the recess surface defining an opening between thedistal base and the proximal lateral projection, and with the openingconfigured to receive therein a rotatable driver for rotating the shaft.

In another aspect, a method of repositioning an implant for reshaping aheart valve annulus is described. The implant comprises a shaft, acollar, a pair of struts, and an anchor. The method comprises rotatingthe shaft in a first direction, translating the collar proximally alongthe pair of struts, increasing an angle between the pair of struts,disengaging the anchor from a first location of tissue of the heartvalve annulus, engaging the anchor with a second location of the tissueof the heart valve annulus, rotating the shaft in a second direction,translating the collar distally along the pair of struts, and decreasingthe angle between the pair of struts. In some embodiments, disengagingthe anchor from the first location comprises rotating the anchor in athird direction, and engaging the anchor with the second locationcomprises rotating the anchor in a fourth direction.

In another aspect, a method of retrieving an implant secured with aheart valve annulus of a patient is described. The implant comprises ashaft, a collar, a pair of struts, and an anchor. The method comprisesrotating the shaft in a first direction, translating the collarproximally along the pair of struts, increasing an angle between thepair of struts, disengaging the anchor from tissue of the heart valveannulus, rotating the shaft in a second direction, translating thecollar distally along the pair of struts, decreasing the angle betweenthe pair of struts, receiving the implant in a delivery catheter, andremoving the implant from the patient.

In another aspect, an implant for dynamic post implantation constrictionof an annulus surrounding a heart valve is described. The implantcomprises an implant body, a plurality of tissue anchors, and a moveablerestraint. The implant body comprises a proximal end, a distal end, acentral lumen extending therethrough and at least one pair of adjacentstruts joined at an apex and having an angle there between. Theplurality of tissue anchors are on the implant body, and the anchors areconfigured to embed into tissue surrounding the heart valve. Themoveable restraint is at least partially surrounding the pair ofadjacent struts and can be moved along the pair of adjacent struts awayfrom the apex to reduce the angle between the pair of adjacent struts,thereby causing the implant body to contract the annulus from a firstdiameter to a second, smaller diameter with at least one strut initiallyelastically deflected by resistance to movement imposed by the annuluswhen in the second diameter. The implant is configured to contract postimplantation from the second diameter to a third, smaller diameter aselastic tension in the strut relaxes and overcomes resistance tomovement imposed by the annulus. In some embodiments, the elastictension is stored in the struts in between the movable restraint and atissue anchor.

In another aspect, a method of dynamic post implantation constriction ofan annulus surrounding a heart valve is described. The method comprisesthe steps of securing an implant to the wall of the atrium surrounding amitral valve annulus having a first diameter, actively adjusting theimplant with an adjustment catheter to reduce the annulus from the firstdiameter to a second, smaller diameter, removing the adjustmentcatheter, and continuing to reduce the diameter to a third diameter,smaller than the second diameter following removal of the catheter, inresponse to potential energy stored in the implant.

Various embodiments of the various aspects are described. For example,the second diameter may be no more than about 27 mm and the thirddiameter may be at least 1 mm smaller than the second diameter. Thesecond diameter may be no more than about 27 mm and the third diametermay be at least 2 mm smaller than the second diameter. The implant maybe configured to contract post implantation from the second diameter toa third, smaller diameter within about 30 days from the removing theadjustment catheter step. Mitral leaflet coaptation may increase by atleast about 25% in response to reduction of the annulus from the seconddiameter to the third diameter. Mitral leaflet coaptation may increaseby at least about 50% in response to reduction of the annulus from thesecond diameter to the third diameter. The diameter may continue toreduce for at least about five days following the removing theadjustment catheter step. The diameter may continue to reduce for atleast about 10 days following the removing the adjustment catheter step.

In another aspect, a method of increasing mitral valve leafletcoaptation following implantation of a dynamic mitral valve annulusconstriction device is described. The method comprises the steps ofsecuring an implant to the wall of the atrium surrounding a mitral valveannulus having a first diameter, actively adjusting the implant with anadjustment catheter to reduce the annulus from the first diameter to asecond, smaller diameter, and removing the adjustment catheter.Following the removing the catheter step, the dynamic implant increasesleaflet coaptation by at least about 25% from the coaptationcorresponding to the second diameter. In some embodiments, following theremoving the catheter step the dynamic implant increases leafletcoaptation by at least about 50% from the coaptation corresponding tothe second diameter. In some embodiments, following the removing thecatheter step, the dynamic implant increases leaflet coaptation by atleast about 2 mm. In some embodiments, following the removing thecatheter step the dynamic implant increases leaflet coaptation by atleast about 4 mm.

In another aspect, a method of remodeling a mitral valve annulus, afterimplantation of an implant for reshaping the annulus, is described. Themethod comprises positioning an implant adjacent a mitral valve annulus.The implant comprises a tubular frame having a pair of struts, arotatable shaft carried by the frame, a translatable collar engaged withthe rotatable shaft and at least partially surrounding the pair ofstruts, and an anchor coupled with the frame. The method furthercomprises securing the anchor to tissue of the mitral valve annulus,rotating the shaft to cause the collar to translate along the first pairof struts, decreasing an angle between the first pair of struts due totranslation of the collar, contracting a width of the heart valveannulus to a first reduced width for a period of time longer than twentyfour hours, and subsequent to the period of time, further contractingthe width of the heart valve annulus to a second reduced width that isless than the first reduced width.

In another aspect, an implant for reducing heart valve regurgitation isdescribed. The implant comprises a frame, a plurality of anchoringmembers and a plurality of collars. The frame has upper crowns, lowercrowns and struts between the upper and lower crowns. The frame has atissue engaging configuration having a tissue engaging diameter, and anannulus remodeling configuration where the frame has an annulusremodeling diameter that is less than the tissue engaging diameter. Theplurality of anchoring members are coupled with the lower crowns of theframe for engaging cardiac tissue proximate the heart valve annulus. Theplurality of collars are coupled with the upper crowns of the frame,wherein when force is applied to the collars, the collars slide alongthe upper crowns and the struts to move the frame from the tissueengaging configuration towards the annulus remodeling configuration.

In some embodiments, the plurality of anchoring members are helicallywound anchoring members and the lower crowns of the frame are adapted tothreadingly receive the helically wound anchoring members. The helicallywound anchoring members may further include anchoring heads forengagement with actuators to rotationally advance the helically woundanchoring members in the cardiac tissue to anchor the frame into thecardiac tissue. The implant may further comprise abutments on each ofthe anchor heads to engage with the struts and the lower crowns to limittravel of the helically wound anchoring members. The helically woundanchoring members may have sharpened tips to facilitate penetration ofthe helically wound anchor members into the cardiac tissue.

The implant may further comprise at least one tab on each of thecollars, with the tabs inwardly biased to engage with the upper crownswhen the collars are slid over the upper crowns and struts. The implantmay further comprise a groove formed on an outwardly facing side of theupper crowns and at least one tab on each of the collars with the tabsinwardly biased to engage with the groove. Each of the collars maycomprise a plurality of the tabs, and the plurality of tabs can beadvanced over the upper crowns and struts to selectively vary theannulus remodeling diameter of the frame. The plurality of tabs may bevertically disposed on an outwardly facing portion of the collars andcomprise a lowermost tab, with the lowermost tab initially disposed andengaged with an underside of the upper crown.

The implant may further comprise a plurality of pusher members thatengage with the plurality of collars to forcibly advance the collarsover the upper crowns and struts to reduce the diameter of the frame.

The implant may further comprise flex sections on the collars tofacilitate advancement of the collars over the upper crowns and struts.

The frame may define a longitudinal axis, and the lower crowns andanchoring members received in the lower crowns may be inclined outwardlyin a distal direction at an angle between about 30° to about 60° withrespect to a portion of the axis that extends distally below theimplant.

In another aspect, a delivery system for delivering an implant forreducing heart valve regurgitation is described. The delivery systemcomprises the implant, a delivery catheter, and an imaging catheter. Theimplant comprises a frame, a plurality of anchoring members and aplurality of collars. The frame has upper crowns, lower crowns andstruts between the upper and lower crowns, and a tissue engagingconfiguration with a tissue engaging diameter and an annulus remodelingconfiguration where the frame has an annulus remodeling diameter lessthan the tissue engaging diameter. The plurality of anchoring membersare coupled with the lower crowns of the frame for engaging cardiactissue proximate the heart valve annulus. The plurality of collars arecoupled with the upper crowns of the frame, and when force is applied tothe collars, the collars slide on the upper crowns and the struts tomove the frame from the tissue engaging configuration towards theannulus remodeling configuration. The delivery catheter is releasablyattached to the implant and is configured to deliver the implant to aposition proximate the heart valve annulus. The imaging cathetercomprises a distal end configured to extend proximate the heart valveannulus and to capture one or more images therein of the position of theimplant relative to the heart valve annulus.

In some embodiments, the delivery system further comprises a pluralityof actuating members for engaging corresponding anchoring members of theimplant to cause the anchoring members to penetrate and advance into thecardiac tissue to anchor the frame in position proximate the heart valveannulus. The delivery system may further comprise a plurality of pushermembers for engaging corresponding collars of the implant to forciblyadvance each collar over its respective upper crown and struts therebyreducing the diameter of the frame and the valve annulus. The deliverysystem may further comprise means for centering the imaging catheterwith respect to the implant. The distal end of the imaging catheter maycomprise longitudinally disposed and circumferentially disposedultrasound transducers. The frame may define a longitudinal axis, andthe lower crowns and anchoring members received in the lower crowns maybe inclined outwardly in a distal direction at an angle of approximately45° with respect to a portion of the axis that extends distally belowthe implant.

In some embodiments, the delivery system may further comprise a loopencircling the frame proximate its lower crowns, and a constrictingactuator to constrict the loop to facilitate collapse and loading of theimplant into the delivery system. Each of the collars may comprise aplurality of tabs that are inwardly biased to engage with correspondingundersides of the upper crowns when the collars are slid over the uppercrowns and struts by the pusher members. After the frame has beenanchored into the cardiac tissue, the loop may be constricted todetermine the desired reduction in diameter of the frame prior toadvancing the collars and tabs over the respective upper crowns andstruts.

In another aspect, a method of reducing the size of an enlarged heartvalve annulus is described. The method comprises the steps of deliveringan implant in a delivery system to a site above and proximate theenlarged heart valve annulus, the implant having a proximal end and adistal end; releasing the implant from the delivery system to allow theimplant to take on a tissue engaging diameter; anchoring the distal endof the implant into cardiac tissue proximate and above the enlargedheart valve annulus; translating a plurality of collars overcorresponding upper crowns of the proximal end of the implant to reducethe tissue engaging diameter to an annulus remodeling diameter, therebyreducing the size of the enlarged heart valve annulus; and disengagingthe anchored and reduced diameter implant from the delivery system.

In another aspect, a heart valve replacement implant is described. Theheart valve replacement implant comprises a replacement valve, a tubularvalve housing, a cinch frame, a plurality of anchoring members and aplurality of collars. The replacement valve has a plurality ofreplacement valve leaflets. The tubular valve housing is fixedlyattached to the replacement valve leaflets. The cinch frame is connectedto and circumferentially surrounds the tubular valve housing. The cinchframe has upper crowns, lower crowns and struts between the upper andlower crowns, and is configurable between a tissue engagingconfiguration with opposing upper crowns separated by a tissue engagingdiameter and an annulus remodeling configuration with opposing uppercrowns separated by an annulus remodeling diameter that is less than thetissue engaging diameter. The plurality of anchoring members are coupledwith the upper crowns of the cinch frame for engaging cardiac tissueproximate the heart valve annulus. The plurality of collars are coupledwith the lower crowns of the cinch frame. When force is applied to thecollars, the collars slide on the lower crowns and the struts toreconfigure the cinch frame from the tissue engaging configurationtowards the annulus remodeling configuration.

In some embodiments, the heart valve replacement implant furthercomprises a sealing flange on the cinch frame that is disposed on theatrial side of the heart valve when the heart valve replacement systemis implanted.

In another aspect, a heart valve replacement implant is described. Theheart valve replacement implant comprises a replacement valve, a tubularvalve, a cinch frame, a plurality of anchoring members and a pluralityof collars. The replacement valve has a plurality of replacement valveleaflets. The tubular valve housing is fixedly attached to thereplacement valve leaflets. The cinch frame is connected to andcircumferentially surrounds the tubular valve housing. The cinch framehas upper crowns, lower crowns and struts between the upper and lowercrowns, and is configurable between a tissue engaging configuration withopposing lower crowns separated by a tissue engaging diameter and anannulus remodeling configuration with opposing lower crowns separated byan annulus remodeling diameter that is less than the tissue engagingdiameter. The plurality of anchoring members are coupled with the lowercrowns of the cinch frame for engaging cardiac tissue proximate theheart valve annulus. The plurality of collars are coupled with the uppercrowns of the cinch frame. When force is applied to the collars, thecollars slide on the upper crowns and the struts to reconfigure thecinch frame from the tissue engaging configuration towards the annulusremodeling configuration.

In some embodiments, the tubular valve housing has a proximal end and adistal end, and the upper crowns of the cinch frame have extensionsadapted to be received in openings in the proximal end of the valvehousing such that the upper crowns and the cinch frame pivot about theproximal end of the valve housing.

In another aspect, an implant for reshaping a mitral valve annulus isdescribed. The implant comprises a tubular frame, a shaft and a collar.The tubular frame has a proximal end, a distal end and a central lumenextending therethrough. The frame comprises a first pair of adjacentstruts joined at a proximal apex. The shaft is carried by the proximalapex. The shaft extends along a rotation axis and has an externalthread. The shaft is configured to rotate about the rotation axis. Thecollar is carried by the frame and has an opening extending axiallytherethrough in which to receive the shaft. The collar has acomplementary surface structure for engaging the threads of the shaft.The collar is configured to at least partially surround the first pairof adjacent struts. Rotation of the shaft about the rotation axis in afirst rotation direction causes the collar to advance along the firstpair of struts toward the distal end of the frame to decrease an anglebetween the first pair of adjacent struts.

In some embodiments, rotation of the shaft about the rotation axis in asecond rotation direction that is opposite the first rotation directioncauses the collar to advance along the first pair of struts toward thedistal end to allow an increase in the angle between the first pair ofadjacent struts.

In some embodiments, the implant may further comprise an anchor coupledwith the frame, with the anchor configured to engage tissue of themitral valve annulus. The frame may comprise a second pair of adjacentstruts joined at a distal apex, and the anchor is coupled with thedistal apex. The anchor may be a helical anchor. The distal apex mayinclude a series of openings configured to rotatably receive the anchortherethrough.

In some embodiments, the frame may further comprise a window at theproximal apex, the window configured to at least partially retain theshaft therein. The frame may further comprise a first support and asecond support, with the first and second supports extending from theapex toward the proximal end and at least partially defining the windowon opposite sides of the shaft.

In some embodiments, the complementary surface structure of the collarmay comprise an internal thread disposed along at least a portion of oneor more inner surfaces of the collar. The internal thread may be acentrally threaded bore of the collar. The internal thread may bedisposed along first and second inner surfaces from a proximal end to adistal end of the collar. The complementary surface structure of thecollar may comprise a series of teeth extending along one or more innersurfaces of the collar. The opening of the collar may further comprise afirst channel and a second channel, and the first pair of adjacentstruts may include a first strut and a second strut, with the firstchannel configured to receive the first strut, and the second channelconfigured to receive the second strut.

In some embodiments, the implant of claim 1, further comprising acoupling attached to a proximal end of the shaft, the couplingconfigured to be rotated by a driver coupling to rotate the shaft. Thecoupling may comprise a lateral projection having a proximally facingrecess surface for engaging the driver coupling.

In some embodiments, the tubular frame defines a central longitudinalaxis, and the adjacent pair of struts are configured to incline radiallyoutward relative to the central longitudinal axis. The adjacent pair ofstruts may be configured to incline radially outward relative to thecentral longitudinal axis in response to decreasing the angle betweenthe first pair of adjacent struts.

In some embodiments, the implant may further comprise a plurality of thefirst pair of adjacent struts with each pair joined at a respectiveproximal apex, a plurality of the shafts each carried by the respectiveproximal apex. and a plurality of the collars each configured to engagea respective shaft.

In another aspect, an implant for reshaping a mitral valve annulus isdescribed. The implant comprises a tubular frame, a shaft and a collar.The tubular frame comprises a first pair of adjacent struts joined at anapex. The shaft is carried by the frame and extends along a rotationaxis, the shaft having a radial engagement structure. The collar iscarried by the frame and at least partially surrounds the first pair ofadjacent struts, the collar having an internal complementary surfacestructure for engaging the radial engagement structure of the shaft.Rotation of the shaft about the rotation axis causes the collar toadvance along the first pair of struts to change an angle between thefirst pair of adjacent struts.

In another aspect, a method of reshaping a mitral valve annulus isdescribed. The method comprises positioning an implant adjacent a mitralvalve annulus. The implant comprises a tubular frame having a pair ofstruts, a rotatable shaft carried by the frame, a translatable collarengaged with the rotatable shaft and at least partially surrounding thepair of struts, and an anchor coupled with the frame. The method furthercomprises securing the anchor to tissue of the mitral valve annulus,rotating the shaft to cause the collar to translate along the first pairof struts, and decreasing an angle between the first pair of struts dueto translation of the collar.

BRIEF DESCRIPTION OF THE DRAWINGS

The foregoing and other features of the present disclosure will becomemore fully apparent from the following description and appended claims,taken in conjunction with the accompanying drawings. Understanding thatthese drawings depict only several embodiments in accordance with thedisclosure and are not to be considered limiting of its scope, thedisclosure will be described with additional specificity and detailthrough use of the accompanying drawings. In the following detaileddescription, reference is made to the accompanying drawings, which forma part hereof. In the drawings, similar symbols typically identifysimilar components, unless context dictates otherwise. The illustrativeembodiments described in the detailed description, drawings, and claimsare not meant to be limiting. Other embodiments may be utilized, andother changes may be made, without departing from the spirit or scope ofthe subject matter presented here. It will be readily understood thatthe aspects of the present disclosure, as generally described herein,and illustrated in the drawing, can be arranged, substituted, combined,and designed in a wide variety of different configurations, all of whichare explicitly contemplated and make part of this disclosure.

FIG. 1 is a perspective view of an embodiment of an implant, having aframe, collars and anchors, for reshaping a heart valve annulus.

FIG. 2 is a perspective view of the implant of FIG. 1 shown in anunconstrained state.

FIG. 3 is a perspective view of the implant of FIG. 1 shown in ananchored state.

FIG. 4 is a perspective view of the implant of FIG. 1 shown in a cinchedstate.

FIGS. 5A-5E are various views of embodiments of a collar and frame thatmay be used with the implant of FIG. 1.

FIGS. 6A and 6B are side views of embodiments of a collar and frame thatmay be used with the implant of FIG. 1 shown, respectively, in anexpanded and a cinched state.

FIGS. 7A through 7D show, respectively, a circumferentially outwardfacing view, a side view, a circumferentially inward facing view, and aperspective view of an embodiment of a collar having locking tabs.

FIGS. 8A through 8C are various views of an embodiment of a collarhaving cutouts that may be used with the implant of FIG. 1.

FIG. 9 is a perspective view of an embodiment of a collar with lockingtabs.

FIGS. 10 and 11 are perspective views of an embodiment of an implanthaving collars with locking tabs shown, respectively, in an expanded anda cinched state.

FIGS. 12 and 13 are perspective views of an embodiment of an implanthaving collars with cutouts shown, respectively, in an expanded and acinched state.

FIGS. 14 and 15 are perspective views of an embodiment of an implanthaving collars with locking tabs shown, respectively, in an expanded anda cinched state.

FIGS. 16 and 17 are partial side views of an embodiment of an implanthaving a rotational member and filament for cinching adjacent struts ofthe implant.

FIGS. 18 and 19 are partial side views of an embodiment of an implanthaving two strings for cinching adjacent struts of the implant.

FIG. 20 is a partial side of an embodiment of an implant having anaxially displaceable circumferential filament for cinching the frame ofthe implant.

FIGS. 21A through 21D are partial sequential side views of an embodimentof a frame showing sequential cinching of adjacent struts using a stringmember and tabs.

FIGS. 22A through 22E are perspective views of various embodiments ofdelivery systems having positioning and imaging capabilities that may beused to deliver the various implants described herein.

FIG. 23 is a side view of an embodiment of an intravascular cardiacechography (ICE) catheter for delivering, e.g. aligning and positioning,the various implants described herein, and having a guidewire enteringand exiting the catheter.

FIGS. 24A through 24D are perspective views of another embodiment of anICE catheter and delivery system for delivering, e.g. aligning andpositioning, the various implants described herein and having a circulararray of sensors at the tip of the catheter, e.g. for radial and/orcircumferential echo views.

FIGS. 25A through 25E are sequential perspective views of an embodimentof a delivery system with imaging capability showing an embodiment of amethod for the delivery, positioning and anchoring of the variousimplants described herein for resizing the native valve annulus.

FIG. 26 is a side view of an embodiment of an implant having aconstricting loop and is shown interacting with a delivery system foradvancing the collars.

FIGS. 27A and 27B are side and detail views, respectively, of anembodiment of an implant having a cinch loop and is shown interactingwith a delivery system for advancing the anchors.

FIG. 28 is a perspective view of an embodiment of a delivery systemhaving an implant attached thereto for delivery and securement of theimplant to a heart valve annulus.

FIG. 29 is a cross section view taken along line 29-29 of FIG. 28showing the internal features of a portion of the delivery system ofFIG. 28.

FIGS. 30A through 30C are perspective views of a replacement heart valveimplant with anchors coupled to upper crowns and collars coupled withlower crowns and having a sealing atrial flange and shown, respectively,in a unconstrained state, an anchored state, and a cinched state.

FIG. 31 is a cross-section view of a heart showing the replacement heartvalve implant of FIGS. 30A through 30C deployed across a native mitralvalve of the heart.

FIGS. 32A and 32B are perspective views of an embodiment of areplacement heart valve implant with anchors coupled to upper crowns andshown, respectively, in an anchored state and a cinched state.

FIGS. 33A and 33B are perspective and side views of an embodiment of areplacement heart valve implant having a cinch frame and a housing andshown, respectively, in a deployed, unconstrained state and in ananchored, cinched and locked state.

FIGS. 34A and 34B are side views of an embodiment of a distal section ofa steerable catheter shown in straight and flexed states, respectively,that may be used to deliver the various implants described herein.

FIGS. 35A and 35B are side views of an embodiment of a distal section ofa steerable catheter having a spine that may be used to deliver thevarious implants described herein.

FIGS. 36A and 36B are side views of another embodiment of a distalsection of a steerable catheter having a thin film that may be todeliver the various implants described herein.

FIG. 37 is a side view of another embodiment of a distal section of asteerable catheter having nesting elements that may be used to deliverthe various implants described herein.

FIG. 38A is a perspective view of another embodiment of an implanthaving a rotatable threaded shaft nested within the frame and locatedinternally to an axially translatable collar at the proximal apexes,with helical anchors engaged with openings in the distal apexes.

FIG. 38B is a flattened side view of a portion of the implant of FIG.38A having certain features removed for purposes of illustration and therotatable shafts shown with elongated proximal members instead ofproximal couplings.

FIG. 39 is a partial perspective view of a proximal apex of the implantof FIG. 38A including an embodiment of an end cap for retaining therotatable threaded shaft.

FIG. 40A is a partial perspective view of another embodiment of animplant having an axially translatable collar and a rotatable threadedshaft nested within the frame and located internally to the collar andwith a coupling for engagement by a driver coupling for rotating thethreaded shaft to cause axial movement of the collar.

FIG. 40B is a partial perspective view of an embodiment of a drivercoupling that may be used with the implant coupling of FIG. 40A.

FIG. 41 is a partial perspective view of another embodiment of animplant having an axially translatable collar that is contoured and arotatable threaded shaft nested within the frame and located internallyto the collar and with a coupling for engagement by a driver forrotating the threaded shaft to cause axial movement of the collar.

FIG. 42 is a flattened perspective view of another embodiment of animplant having an axially translatable collar and a rotatable threadedshaft surrounding a proximal post of the frame and located internally ofa rounded collar.

FIG. 43 is a flattened perspective view of another embodiment of animplant having an axially translatable collar and a rotatable threadedshaft surrounding a proximal post and pin of the frame and locatedinternally to the collar.

FIGS. 44A-44C depict various views of an embodiment of an implant havingflared proximal ends, for example after anchoring the implant to hearttissue.

FIGS. 45A-45B are cross-section views of various embodiments of a collarthat may be used with the various implants described herein.

FIG. 46 is a flowchart showing an embodiment of a method for reshaping amitral valve annulus using the various implants described herein.

FIG. 47A is a perspective view of another embodiment of an implanthaving a rotatable threaded shaft nested within the frame and locatedinternally to an axially translatable collar at the proximal apexes, andhaving anchor assemblies with anchor housings at distal apexes.

FIG. 47B is a perspective view of the implant of FIG. 47A having anchorassemblies with anchor housings at distal apexes and with certainfeatures at the proximal apexes removed for purposes of illustration.

FIG. 48 is a partial perspective view of the interior of the implant ofFIG. 47A, showing an embodiment of a cinching assembly at the proximalend of the frame having a rotatable threaded shaft and an axiallytranslatable collar shown in a distal position along a pair of adjacentstruts, and an anchor assembly at the distal end of the frame having ahousing and a corresponding anchor in a retracted proximal position.

FIG. 49A is a detailed perspective view of the exterior of the implantof FIG. 47A showing an anchor assembly at a distal apex of the framewith the anchor housing engaged with the distal apex.

FIG. 49B is a partial perspective view of the distal end of the implantof FIG. 47A showing an interior view of an anchor assembly attached at adistal apex of the frame with the anchor housing engaged with the distalapex.

FIG. 50A is a side view of an embodiment of an anchor having a distalhelical tissue engagement portion and a proximal head, that may be usedwith the various implants.

FIG. 50B is a detail view of the anchor assembly of the implant of FIG.47A showing an interface between the anchor and a proximal end of theanchor housing.

FIG. 51 is a partial cross-section view of an interface between theanchor and a proximal end of the anchor housing of FIG. 47A, showing thedistal helical tissue engagement portion engaging internal grooves inthe anchor housing.

FIG. 52 is a partial cross-section view of the interface of FIG. 51between the proximal end of the housing and the anchor, showing thedistal helical tissue engagement portion moved proximally relative tothe position shown in FIG. 51 and disengaged from the internal groovesin the anchor housing.

FIGS. 53A and 53B are respectively proximal end and perspective views ofthe anchor housing of FIG. 47A.

FIG. 54 is a partial cross-section view of the anchor assembly of FIG.47A showing the anchor housing having the anchor therein engaged with adriver.

FIG. 55 depicts the anchor assembly of FIG. 47A showing the driverdisengaged from the anchor head with the anchor head having been pulledinto a self-locking position within the anchor housing.

FIGS. 56-59 are partial perspective views depicting sequentialpositioning of the anchor with the driver, engagement of tissue with theanchor, de-coupling of the driver from the anchor, and settling in ofthe anchor with the housing.

DETAILED DESCRIPTION

The following detailed description is directed to certain specificembodiments of the development. In this description, reference is madeto the drawings wherein like parts or steps may be designated with likenumerals throughout for clarity. Reference in this specification to “oneembodiment,” “an embodiment,” or “in some embodiments” means that aparticular feature, structure, or characteristic described in connectionwith the embodiment is included in at least one embodiment of theinvention. The appearances of the phrases “one embodiment,” “anembodiment,” or “in some embodiments” in various places in thespecification are not necessarily all referring to the same embodiment,nor are separate or alternative embodiments necessarily mutuallyexclusive of other embodiments. Moreover, various features are describedwhich may be exhibited by some embodiments and not by others. Similarly,various requirements are described which may be requirements for someembodiments but may not be requirements for other embodiments.

The implants, delivery systems, methods, and features thereof that areshown in and described with respect to FIGS. 1-37 may have the same orsimilar features and/or functionalities as other implants, deliverysystems, methods, and features thereof described herein, such as theimplant 1 described with respect to FIGS. 38A-59, and vice versa. Thus,any of the implants described herein may have rotatable shafts 646 thatengage axially translatable collars 18, and/or anchor assemblies 20Awith helical anchors 20 and anchor housings 22A, as further describedherein.

FIGS. 1-4 are perspective views of an embodiment of an implant 1. Theimplant 1 is intended to be delivered proximate to, above and/or orwithin, the cardiac valve annulus. Unless otherwise stated, “valve” asused herein may refer to any of a variety of valves, including thetricuspid or mitral valve of the heart. The implant 1 may besubsequently implanted in the annular cardiac tissue just above theplane of the valve orifice. In some embodiments, the implant may be aheart valve replacement including valve leaflets, which can be implantedin annular cardiac tissue and extend into the valve annulus, as furtherdescribed herein.

Particular features for various embodiments of an implant, of a deliverysystem, and of related systems and methods of use of the implant anddelivery system (either together or separately), are described herein.The implant, delivery system, and related systems and methods of use mayhave the same or similar features and/or functionalities as otherimplants, delivery systems, and related systems and methods of use asdescribed, for example, in U.S. patent application Ser. No. 14/861,877entitled “ADJUSTABLE ENDOLUMENAL IMPLANT FOR RESHAPING MITRAL VALVEANNULUS and filed on Sep. 22, 2015 (issued on Apr. 11, 2017, as U.S.Pat. No. 9,615,926), as described, for example, in U.S. ProvisionalApplication No. 62/234,592 entitled “HEART VALVE DELIVERY SYSTEM WITHINTRAVASCULAR ULTRASOUND IMAGING CAPABILITY” and filed on Sep. 29, 2015,as described, for example, in U.S. patent application Ser. No.15/280,004 entitled “METHODS FOR DELIVERY OF HEART VALVE DEVICES USINGINTRAVASCULAR ULTRASOUND IMAGING” and filed on Sep. 29, 2016, asdescribed, for example, in U.S. patent application Ser. No. 15/043,301entitled “VALVE REPLACEMENT USING ROTATIONAL ANCHORS” and filed on Feb.12, 2016 (issued on Dec. 26, 2017, as U.S. Pat. No. 9,848,983), asdescribed, for example, in U.S. patent application Ser. No. 15/352,288entitled “IMPLANTABLE DEVICE AND DELIVERY SYSTEM FOR RESHAPING A HEARTVALVE ANNULUS” and filed on Nov. 15, 2016, as described, for example, inU.S. Provisional Patent Application No. 62/457,441 entitled “IMPLANTABLEDEVICE AND DELIVERY SYSTEM FOR RESHAPING A HEART VALVE ANNULUS” andfiled on Feb. 10, 2017, as described, for example, in U.S. ProvisionalPatent Application No. 62/552,896 entitled “IMPLANTABLE DEVICE ANDDELIVERY SYSTEM FOR RESHAPING A HEART VALVE ANNULUS” and filed on Aug.31, 2017, as described, for example, in U.S. patent application Ser. No.12/794,235 entitled “DEVICE FOR TRANSLUMENAL RESHAPING OF A MITRAL VALVEANNULUS” and filed on Jun. 4, 2010, as described, for example, in U.S.patent application Ser. No. 14/567,872 entitled “RECONFIGURING TISSUEFEATURES OF A HEART ANNULUS” and filed on Jun. 4, 2010 (issued on Oct.24, 2017, as U.S. Pat. No. 9,795, 480), as described, for example, inU.S. patent application Ser. No. 14/427,909 entitled “MITRAL VALVEINVERSION PROSTHESES” and filed on Mar. 12, 2015 (issued on Apr. 4,2017, as U.S. Pat. No. 9,610,156), and/or as described, for example, inU.S. patent application Ser. No. 14/774,656 entitled “SYSTEMS ANDMETHODS FOR RESHAPING A HEART VALVE” and filed on Sep. 10, 2015, theentire disclosure of each of which is incorporated herein by referencefor all purposes and forms a part of this specification. Thus, thedescription of particular features and functionalities herein is notmeant to exclude other features and functionalities, such as thosedescribed in the references incorporated herein by reference or otherswithin the scope of the development.

With reference to FIG. 1, the implant 1 is an implantable device. Theimplant 1 forms a lumen or opening 3 extending through the implant 1.For sake of description, a geometric reference longitudinal axis isindicated. The implant 1 may be described with reference to the axis. An“axial” direction refers to movement generally parallel to the axis ineither an upward or downward direction, unless otherwise indicated. Theopening 3 extends axially between an upper portion 2 of the implant 1and a lower portion 4 of the implant 1. The upper and lower portions 2,4 may include various features of the implant 1. The terms “upper,”“upward,” and the like refer to directions generally toward the upperportion or proximal end 2, and the terms “lower,” “downward,” and thelike refer to directions generally toward the lower portion or distalend 4, unless otherwise indicated. “Proximal” refers to a direction inthe upward direction, and “distal” refers to a direction in the downwarddirection. The terms “inner,” “inward,” and the like refer to directionsgenerally toward the axis, and terms “outer,” “outward,” and the likerefer to directions generally away from the axis. These geometricreferences generally apply unless otherwise indicated, either explicitlyor by context.

The implant 1 includes a frame 10. The frame 10 extendscircumferentially around and partially axially along the axis. The axismay be defined by the frame 10. The frame 10 is generally symmetric withrespect to the axis. However, the frame 10 need not be symmetric withrespect to the axis. The frame 10 has a generally tubular shape.“Tubular” includes circular as well as other rounded or otherwise closedshapes. The frame 10 is generally circular about the axis. The frame 10may be circular, rounded, ellipsoidal, segmented, other shapes, orcombinations thereof. The frame 10 may change shape, size,configuration, etc. The frame 10 may have various shapes, sizes,configurations etc. at various phases of use, e.g. pre-delivery, duringdelivery, after engagement with tissue, after contracting the annulus,post-contraction, during the lifetime of use while implanted, etc.

The implant 1 includes one or more struts 12. The struts 12 may form allor part of the frame 10. The struts 12 are elongated structural members.The struts 12 and/or other parts of the frame 10 are formed of a metalalloy. The struts 12 and/or other parts of the frame 10 may be formed ofan alloy of nickel titanium. In some embodiments, the struts 12 and/orother parts of the frame 10 are formed of other metals, metal alloys,plastics, polymers, composites, other suitable materials, orcombinations thereof. There are sixteen struts 12. In some embodiments,there may be fewer or more than sixteen struts 12. In some embodiments,there may be at least two, four, six, eight, ten, twelve, fourteen,eighteen, twenty, twenty-two, twenty-four, twenty-six, twenty-eight,thirty, or more struts 12.

The struts 12 may be part of the same, monolithic piece of material(e.g. tube stock). Thus the struts 12 may refer to different portions ofthe same, extensive component. The struts 12 may be formed from the samepiece of material. The struts 12 may be formed separately and attachedpermanently together, e.g. by welding, etc. In some embodiments, thestruts 12 may be separate components that are detachably coupledtogether by other components of the implant 1. For example, the struts12 may be held together via various components described herein, such ascollars 18, anchors 20, other features, or combinations thereof. In someembodiments, separate strut units may include two or more strutspermanently attached together such as at an apex, and the separate unitsmay each be coupled together, either permanently or detachably, to formthe frame 10. In some embodiments, the struts 12 may be attached byhinges, pins, or other suitable means.

The elongated, middle portions of the struts 12 have a generallyrectangular cross-section but can vary in circumferential width andradial thickness to allow for different beam characteristics and forcesapplied as the collars are advanced. This may facilitate for examplepost implantation constriction or remodeling of the annulus, as furtherdescribed. The long ends of the rectangular cross-section of the struts12 extend along the circumference of the frame 10. “Circumference” asused herein generally refers to a perimeter or boundary and can refer toa circular or other rounded or non-rounded path lying in a planesubstantially transverse to the axis, unless otherwise stated. The shortends of the rectangular cross-section of the struts 12 extendtransversely to the circumference of the frame 10. In some embodiments,other configurations and/or cross-sectional shapes of the struts 12 maybe implemented. The cross-section may be rounded, circular, othershapes, or combinations thereof.

The struts 12 extend around the axis to form the various shapes of theframe 10. The struts 12 are arranged such that the wall pattern of theframe 10 may be approximately sinusoidally or zig-zag shaped. In someembodiments, the wall pattern may have other suitable shapes, sinusoidalor otherwise. The vertices of the sinusoidal shaped frame 10 may bepointed or rounded.

Pairs of adjacent struts 12 meet at an apex. At least a first pair ofadjacent struts 12 meets at an upper apex or crown 14 at the upperportion 2 of the implant 1. At least a second pair of adjacent struts 12meets at a lower apex or crown 16 at the lower portion 4 of the implant1. The terms “apex,” apices,” and the like may be used interchangeablywith terms “crown,” “crowns,” and the like, as used herein and as usedin any reference incorporated by reference herein, unless otherwisestated. The upper and lower crowns 14, 16 are spaced sequentially alongthe circumference of the frame 10, with one of the upper crowns 14followed by one of the lower crowns 16, followed by another one of theupper crowns 14, etc. In the illustrated embodiment, there are eightupper crowns 14 and eight lower crowns 16. In some embodiments, theremay be no more than about six or four or fewer or more than eight or tenor twelve upper and lower crowns 14, 16, depending on the number ofstruts 12 and the resulting number of apices.

The upper crowns 14 are each configured to have a restraint such as acollar 18 fitted over and/or around the upper crown 14. Thus, the uppercrowns 14 may include various features, dimensions, etc. as describedherein for coupling with the collar 18, as further described. The uppercrowns 14 are shown partially covered by the collars 18 in FIG. 1. Theupper ends of the upper crowns 14 are more clearly seen in FIG. 4, wherethe collars 18 have been moved distally toward the lower portion 4 ofthe implant 1 relative to their position in FIG. 1. In some embodiments,one or more of the upper crowns 14 may not have the collar 18. In someembodiments, fewer than all of the upper crowns 14 are configured toreceive the collar 18. In some embodiments, all of the upper crowns 14may be configured to receive the collar 18 but when implanted only someof the upper crowns 14 may actually include the collar 18.

At least two and optimally at least four or six or all of the lowercrowns 16 are configured for coupling with an anchor 20. The anchor 20is moveably coupled with the lower crown 16. The anchor 20 engages withtissue of the heart, for example the annulus, to secure the implant 1 tothe tissue, as further described herein. Movement of the anchor 20relative to the lower crowns 16 causes the anchor 20 to penetrate thetissue. The lower crowns 16 may include a variety of engagement featuresto allow such movement of the anchors 20, such as flanges and/or theopenings 17. The lower crowns 16 each include a series of the openings17 extending through the lower crowns 16. The openings 17 extend in twospaced columns in the axial direction along the lower crown 16. Theopenings 17 in each column are alternately located in the axialdirection, as shown, to accommodate receipt of the anchor 20 therein.Other configurations and/or spacings of the openings 17 may beimplemented. For clarity, only some of the openings 17 are labeled inFIG. 1. The openings 17 are shown as circular holes. Other shapedopenings 17 may be implemented.

The openings 17 of the lower crown 16 are configured to rotatablyreceive a helical segment of the corresponding anchor 20 such that theanchor extends sequentially through the openings 17, both while theanchor 20 moves relative to the struts 12 and while the anchor 20 isstationary relative to the struts 12, as further described herein. Insome embodiments, features alternative to or in addition to the openings17 may be used to couple the anchor 20 with the corresponding lowercrown 16. In some embodiments, fewer than all of the lower crowns 16 maybe configured for coupling with the anchor 20. Thus one or more of thelower crowns 16 may not have the openings 17 and/or other features forcoupling with the anchor 20. In some embodiments, all of the lowercrowns 16 may be configured for coupling with the anchor 20, but whenimplanted only some of the lower crowns 16 may actually include theanchor 20.

The struts 12 are reconfigurable about the upper and lower crowns 14,16. Pairs of adjacent struts 12 that meet at the upper and lower crowns14, 16 can move angularly relative to each other. Such movement may bedescribed as a rotation or pivot of the adjacent struts 12 about thecorresponding upper or lower crown 14, 16. For example, two adjacentstruts 12 forming the upper crown 14 may be moved such that the struts12 effectively rotate relative to each other about the upper crown 14.For example, two adjacent struts 12 forming the lower crown 16 may bemoved such that the struts 12 effectively rotate relative to each otherabout the lower crown 16. “Rotation” of the struts 12 as describedincludes pinching together of the struts 12, for example with the collar18 as described herein. Thus, adjacent struts 12 may not include anactual rotatable hinge, pin, or other rotation features. Movement of thestruts 12 closer together to decrease the angle therebetween isdescribed as a “closing” of the struts 12. Movement of the struts 12farther apart to increase the angle therebetween is described as an“opening” of the struts 12.

The struts 12 may be biased to an enlarged cross-sectional configurationin the absence of an external force applied to the struts 12.Application of an external circumferentially compressive force to thestruts 12, for example with the collar 18, causes the struts 12 to moveangularly, for example to close. Movement of the struts 12 in thisclosing manner also causes the implant 1 to decrease itscircumference(e.g. diameter) in the case of a circular implant 1. In itsfree, unconstrained state, the frame 10 may be in an enlargedconfiguration. Application of the compressive circumferential forcecauses the circumference of the frame 10 to reduce. Removal or lesseningof the circumferential force allows the frame 10 to open. Thecircumferential force may be increased or decreased by moving the collar18 farther downward or upward, respectively, in the axial direction, asfurther described herein. The collar 18 may lock in place aftertranslating axially down the upper crown 14 to secure the implant 1 at aparticular width.

The implant 1 includes one or more restraints such as the sliders orcollars 18. The terms “collar,” collars,” and the like may be usedinterchangeably with the terms “slider,” “sliders,” “sliding members,”and the like, as used herein and as used in any reference incorporatedby reference herein, unless otherwise stated. As shown in FIGS. 1-4, theimplant 1 includes eight collars 18. In some embodiments, there may befewer or more than eight collars 18. The number of collars 18 maycorrespond to the number of upper crowns 14. In some embodiments, theremay be fewer collars 18 than upper crowns 14. Thus, in some embodiments,some upper crowns 14 of the frame 10 may not include the collar 18. Thecollars 18 may translate axially due to axial applied force. The collars18 may translate axially due to engagement with a central rotating shaft646, as further described herein, for example with respect to FIGS.38A-48.

The collar 18 couples with the corresponding upper crown 14. The collar18 may be fitted over the upper crown 14. The collar 18 forms an inneropening at least partially therethrough and into which the upper crown14 is received as the collar 18 fits over the upper crown 14. The collar18 may have a rectangular profile as shown. In some embodiments, thecollar 18 may have other profiles, e.g. rounded, segmented, polygonal,other suitable shapes, or combinations thereof. The profile of thecollar 18 may be a closed shape, as shown, or it may be an open shapesuch as a “C” shape. The collar 18 thus at least partially surrounds thecorresponding upper crown 14. As shown, the collar 18 completelysurrounds the corresponding upper crown 14. In some embodiments thecollar 18 may not completely surround the upper crown 14. The collar 18engages with the upper crown 14.

The collar 18 may engage with circumferentially opposed sides of theupper crown 14 and/or adjacent struts 12. The collar 18 engages with andmay be advanced downward over the upper crown 14 to angularly move thecorresponding pair of adjacent struts 12 towards each other. The collar18 may apply a compressive circumferential force to the struts 12 tocause the struts 12 to decrease the angle between the struts 12. Thecircumferential force may be applied inwardly to the struts 12 andtowards the upper crown 14. Thus, a vertical force applied to thecollars 18 may be translated into a circumferential force on the struts12. By “circumferential” it is meant that the direction of the forces isalong the outer perimeter or boundary of the frame 10 as viewed from thetop or bottom of the frame 10, and is not meant to limit the shape ofthe frame 10 to a circle. Movement of the collar 18 over the struts 12moves, e.g. rotates, the struts 12 such that the angle between theadjacent struts 12 decreases. A first circumferential force may beapplied to one of the struts 12 by the collar 18 and a secondcircumferential force that is opposite in direction to the firstcircumferential force may be applied to the adjacent strut 12 by thatsame collar 18. The farther the collar 18 is moved down over the struts12, the more the struts 12 move and the more the angle decreases,causing the frame 10 to decrease in width, e.g. diameter. The struts 12thus move relative to each other about the upper crown 14 due tomovement of the collar 18. The collar 18 may lock in place, for examplewith a locking tab 19.

The collar 18 may include the locking tab 19. The locking tab 19provides an engagement feature for the collar 18 to engage with thestruts 12. The locking tab 19 locks the collar 18 in place on the uppercrown 14 after movement of the collar 18 over the upper crown 14. Thelocking tab 19 is biased toward the inner opening formed by the collar18. The locking tab 19 may be shape set to take on an inwardly orientedbias. The collar 18 and/or features thereof such as the locking tab 19are formed of a nickel titanium alloy such as Nitinol. In someembodiments, the collar 18 and/or features thereof such as the lockingtab 19 are formed of other materials, such as metals, other metalalloys, plastics, polymers, composites, other suitable materials, orcombinations thereof. Further details of various embodiments of thecollar 18, and features thereof such as the locking tab 19, aredescribed herein.

The collars 18 may thus provide one or more functions for the implant 1.In some embodiments, the collars 18 may cinch the frame 10, asdescribed. In some embodiments, the frame 10 may be cinched by featuresin addition to or alternatively to the collars 18, and the collars 18may restrain the frame 10 in the cinched state. In some embodiments, thecollars 18 may thus not cinch the frame 10 but only restrain the frame10 in the cinched state. In some embodiments, the collars 18 may cinchthe frame 10 as well as restrain the frame 10 in the cinched state.

The implant 1 includes one or more anchors 20. In some embodiments, theanchors 20 may be part of anchor assemblies 20A, may include distalhelical portions 26A and proximal anchor heads 24A, and/or may includeproximal coupling 24D, as further described herein, for example withrespect to FIGS. 38A-59. Referring to FIG. 1, the anchors 20 have anchorheads 22 attached at their upper or proximal ends. The anchor head 22may have the same or similar features and/or functionalities as theanchor head 24D further described herein, and vice versa. As shown inFIG. 1, each anchor head 22 may comprise an abutment 24 and anengagement structure such as a hook 26. The abutment 24 may be a capportion on an upper end of the anchor 20. The abutment may becylindrical. The abutment 24 may have a width sized to limit axialadvance of the anchor 20, as described herein. The hooks 26 areelongated, over-hanging members. The hooks 26 may provide an engagementfor a delivery tool. The hooks 26 may interact with a delivery tool torotate and axially advance the anchors 20, as described herein. In someembodiments, features other than the hooks 26 may be used, for exampleeye bolts.

The anchors 20 are made of a suitable biocompatible metal alloy such asstainless steel, cobalt chromium, platinum iridium, nickel titanium,other suitable materials, or combinations thereof. Each anchor 20 issharpened at its distal point, or leading turn, so as to facilitatepenetration into the cardiac tissue. Each anchor 20 may be from aboutten to about fifteen millimeters (mm) in total axial length. In someembodiments, the anchors 20 may be shorter or longer than ten to fifteenmillimeters (mm) in total axial length. By “total” axial length it ismeant the axial length of the anchor 20 from the end of the distalpenetrating tip to the opposite, proximal end of the head 22. Thehelical portion of the anchor 20 may be from about six to about twelvemillimeters (mm) in axial length, i.e. in an axial direction. In someembodiments, the helical portion of the anchor 20 may be shorter orlonger than six to twelve millimeters (mm) in axial length. The anchorhead 22 and/or other non-helical portions of the anchor 20 may be fromabout three to about four millimeters (mm) in axial length. In someembodiments, the anchor head 22 and/or other non-helical portions may beshorter or longer than three to four millimeters (mm) in axial length.The anchors 20 are capable of extending from about four to about sevenmillimeters (mm) axially beyond the corresponding lower crown 16. Forexample, the helical portions of the anchors 20 may extend from four toseven millimeters (mm) into the cardiac tissue. As mentioned, the frame10 is shown with eight upper crowns 14 and eight lower crowns 16 andanchors 20, but this number of apices is shown for illustration purposesand may be varied, for example four upper and lower apices, sixteenupper and lower apices, etc. In some embodiments, regardless of thenumber of apices, each upper crown 14 is fitted with a collar 18 andeach lower crown 16 has a respective anchor 20 threadingly receivedthrough the openings 17 of the anchor 20.

The anchors 20 couple with the lower crowns 16. The anchors 20 may be inthe general shape of a helix. As shown, the openings 17 receivehelically wound anchors 20. The openings 17 are spaced to accommodatethe pitch of the helical anchors 20, for example the spacing between theturns in the helix of the anchor 20. There may be a gap between theinner diameter of the openings 17 and the outer diameter of the anchor20 to allow for free movement of the anchor 20 through the openings 17.There may be a small gap between the inner diameter of the openings 17and the outer diameter of the anchor 20. In some embodiments, there maybe an interference fit between the openings 17 and the anchor 20 or avarying pitch to provide interference between the anchor and frame. Insome embodiments, the anchors 20 may instead engage anchor housings 22Aat the distal apexes 16, as further described herein.

FIGS. 2 through 4 illustrate the implant 1 in various stages of deliveryand deployment. In FIG. 2, the implant has been expelled from a deliverycatheter and is in its unconstrained state above and proximate thecardiac valve annulus. This unconstrained state may be a tissue engagingconfiguration of the implant 1 having a tissue engaging diameter and atissue engaging height. In this unconstrained state, the frame 10 mayhave an overall axial height in the range of 15 to 20 millimeters (mm).This height or range of height will vary even further from this 15 to 20mm range, depending on the number of apices and anchors 20. Morespecifically, the height is smaller with more apices and anchors 20 andis greater with fewer apices and anchors 20. In the embodiment shown inFIG. 2, the frame has a height of approximately 17 millimeters. Otherheights in the unconstrained state are possible, and this particularembodiment is not limiting of the scope of the present disclosure.

FIG. 3 depicts the implant after it has been anchored into the cardiactissue. This anchored state may be an anchored configuration, which mayor may not be similar to the tissue engaging configuration, of theimplant 1 having an anchored diameter and an anchored height. Theanchored diameter of the implant 1 may be less than, equal to, orgreater than the tissue engaging diameter of the implant 1 in the tissueengaging configuration. The anchored height of the implant 1 may be lessthan, equal to, or greater than the tissue engaging height of theimplant 1 in the first configuration. Thus, the implant 1 when engagedwith and anchored into the tissue may be in the tissue engagingconfiguration. The anchors 20 have been rotationally advanced throughthe lower crowns 16 and the tissue piercing end has rotationallyadvanced into the cardiac tissue. The abutments 24 function as a depthcontrol for the anchors 20, limiting the extent of axial travel of thehelical anchors 20 into the cardiac tissue as the abutments 24 seat inthe valley bounded by the lower ends of the adjacent struts 12.

FIG. 4 shows the implant 1 in its contracted or cinched state. Thiscinched state may be an annulus remodeling configuration of the implant1 having an annulus remodeling diameter and an annulus remodelingheight. The annulus remodeling diameter of the implant 1 is less thanthe tissue engaging diameter of the implant 1 in the tissue engagingconfiguration. The annulus remodeling height of the implant 1 may begreater than the tissue engaging height of the implant 1 in the tissueengaging configuration. In the cinched state, the collars 18 have beenmoved downwardly over the upper crowns 14 until inwardly biased lockingtabs 19 engage with the gap or valley bounded by the upper portions ofadjacent struts 12, below the underside of the upper crowns 14. Thisengagement of the locking tabs 19 to the valley under the upper crowns14 locks the implant into its cinched position. In an alternateembodiment, cut-outs may be formed on the upper crowns 14 to accept thelocking tabs 19.

The implant 1 in it cinched state has a reduced circumference. Thus thecinched implant 1 has a reduced length perimeter or boundary relative tothe unconstrained state. The reduction in circumference need not resultin the same general shape of the implant as before the cinching. Forexample, before cinching, the implant 1 may be in a generallyelliptical, oval or other shape, and after cinching the implant 1 may bein a general “D” shape or other shape (and with a relatively reducedcircumference). Thus, the implant 1 may be in a variety of shapes beforeor after cinching, as well as during cinching. For instance, restraintssuch as the collars 18 may be advanced individually, i.e. notsimultaneously. The implant 1 may thus have an irregular shape whilebeing cinched. In some embodiments, even in the cinched state not all ofthe collars 18 are advanced, and/or are not all advanced the sameamount, such that in the cinched state the angular displacements amongdifferent pairs of adjacent struts may not be the same. The implant 1may thus be cinched in a custom manner depending on the particularpatient's needs. In some embodiments, about half of the implant 1 may becinched, for example to bring the anterior native leaflet closer to theposterior native leaflet, or vice versa. Thus, the “cinched” state ofthe implant 1 is not limited to only those particular shapes shown anddescribed herein, but includes a multitude of possible shapes, sizes,etc. and which may be chosen based on needs of the patient.

FIGS. 5A through 5D are various views of an embodiment of a collar 50that may be used with the implant 1. The collar 50 is shown coupled withthe struts 12 at the upper crown 14. FIGS. 5A and 5B are front views ofa portion of the implant 1, showing the collar 50 coupled with the uppercrown 14 at different axial locations. FIG. 5A shows the implant 1 in aunconstrained state. FIG. 5B shows the collar 50 advanced distallyrelative to the position of the collar 50 shown in FIG. 5A toreconfigure the implant 1 in a cinched state. FIG. 5C is a cross sectionview of the implant 1 taken along line 5C-5C of FIG. 5B. FIG. 5D is afront view of the implant 1 showing a portion of a delivery toolengaging the implant 1.

The collar 50 has multiple locking tabs 54. The locking tabs 54 may havethe same or similar features and/or functionalities as other lockingtabs described herein, for example the locking tabs 19, and vice versa.The locking tabs 54 may be projections or cutouts of the collar 50. Thelocking tabs 54 are biased toward the upper crown 14. The locking tabs54 may therefore contact the upper crown 14. The upper crown 14 mayinclude openings which can receive the ends of the locking tabs 54therein. The upper crown 14 may define a gap in between adjacent struts12 at a valley, as described, which may receive the end of the lockingtabs 54 therein. While two such locking tabs 54 are shown, it should beunderstood that three or more locking tabs 54 could be employed. Theplurality of locking tabs 54 allows the physician/user of the implant 1to adjust the degree of cinch of the implant 1. Increased cinch,resulting in a smaller width of the implant 1 due to contraction, willtend to further reduce the width of the heart valve annulus.

FIGS. 5B and 5C depict the collar 50 advanced distally. The collar 50 asshown may be in its fully advanced state, thus reconfiguring the implant1 to a state of maximum cinch. The uppermost locking tab 54 is engagingthe underside of the upper crown 14. As stated with reference to FIGS.1-4, rather than engaging the underside or upper crown 14, cut-outs inthe upper crown 14 itself can provide the locking engagement with tabs54. Additionally, as best seen in FIG. 5D, the collar 50 has a modifiedor cut out upper section to more readily receive a driver tube 56. Astring member 58, which could take the form of a wire, cable, thread,suture or the like, is used to apply tension to the upper crown 14 asthe driver tube 56 advances the collar 50. The driver tube 56 may be anelongated tube configured to contact and the collar 50 and to apply adownward pressure to the collar 50 to advance the collar 50 along theframe 10. The string member 58 extends through an opening in the uppercrown 14 to counteract the downward force applied by the driver tube 56.This allows the frame 10 to remain stationary axially while the collar50 advances distally to reconfigure the struts 12 and cinch the implant1.

FIG. 5E is a partial side view of the frame 10 coupled with a frequencygenerator 11. The frequency generator 11 may be used with the variousimplants described herein, for example the implant 1, etc. The frame 10is shown with a slider or collar 50′, a pull wire 58′ and a pusher tube56′. The collar 50′, pull wire 58′ and/or pusher tube 56′ may beanalogous to the collar 50, the pull wire 58 and/or the driver tube 56,respectively. To advance the collar 50′ over the frame 10 ahigh-frequency vibration can be added by the frequency generator 11 toassist the movement of the collar 50′. For example, relative vibrationalmovement between the collar 50′ and the frame 10 may produce dynamicmovement that facilitates overcoming a static friction between thecollar 50′ and the frame 10. The vibration could be transmitted throughthe pull-wire 58′ and/or the pusher tube 56′. Vibration of either orboth the pull-wire 58′ or the pusher tube 56′ will transmit the force tothe frame 10 and collar 50′ vibrating the frame 10 and collar 50′ at afrequency to allow an easier movement between the frame 10 and collar50′. An additional tensioning of the pull-wire 58′ during theadvancement will provide a force to the frame 10, changing the frame 10upper apex shape from a wide angle to a more acute angle thus lesseningthe force required to advance the collar 50′. This combination ofpull-force and vibration will lower the push-pull forces required toadvance the collar 50′ over the frame 10. The frequency transmittedthrough the tensioning wire and/or pusher tube 56′ will lower theseforces and could be coupled through each connection. A variety ofsuitable frequency generator tools could be used as the frequencygenerator 11 to transmit these vibrational frequencies, such as a CUSAsystem (Integra® CUSA® EXcel+ Ultrasonic Tissue Ablation System). Thefrequency may be, for example, from 1 to 100 KHz. The frequency can bevaried during the procedure, tailored during the procedure or providedat a fixed defined frequency.

FIGS. 6A and 6B depict an alternate embodiment of the frame 10 and theframe/collar interaction. In addition to the struts 12, the frame 10 isfurther provided with mid-struts 64. The mid-struts 64 have crowns 68and bridge the gap between lower apices 16. Locking tabs 62, of collars60, engage with mid-strut crown 68 as collar 60 is advanced byoperations of wire 58 and driver tube 66. The mid-strut crown 68 may bepulled proximally by the wire 58 to engage the locking tabs 62. Thelocking tabs 62 engage with the underside of mid-strut crowns 68reducing the diameter of the frame 10 and cinching and locking theimplant as shown in FIG. 6B. The collars 60 have sections removed alongtheir sides from proximate mid collar to the collar distal end toaccommodate movement of struts 12 as the collar is advanced over themid-strut crown 68. Also, it is understood that rather than engagingwith the underside of mid-strut crown 68, cut-outs could be provided inthe surface of the mid-strut crowns 68. A driver tube 66 may act todrive the collar 60. The collar 60, locking tabs 62 and driver tube 66may have the same or similar features and/or functionalities as,respectively, the collar 50, the locking tabs 54, and the driver tube56, and vice versa.

FIGS. 7A through 7D are various views of another embodiment of a collar70 that may be used with the various devices, systems and methodsdescribed herein. The collar 70 may have the same or similar featuresand/or functionalities as the other collars described herein, and viceversa. FIGS. 7A, 7B, 7C and 7D show, respectively, a circumferentiallyoutward facing view, a side view, a circumferentially inward facingview, and a perspective view of the collar 70. The collar 70 includeslocking tabs 72, 74. Here the locking tabs 72, 74 are on opposing sidesof the collar 70. Two cut-outs 76 are located proximate the midsectionof the sides of the collar 70. There may be only one or more than twocut-outs 76. Flex sections 78 are provided on either of the lower sidesof the collar 70. There are numerous advantages of these features on thecollar 70. For example, the lower tab 74 acts as a safety tab. As partof the assembly process, the lower tab 74 is positioned into engagementwith a cut out in the upper crown 14, or, alternatively, the undersideof the upper crown 14, of the implant 1. This may, for example, keep thecollar 70 engaged with the upper crown 14 during the rigors of packagingand shipping and during the surgical procedure itself. As furtherexample, both tabs 72, 74 can act as safety tabs by having multiple cutouts on either side of the upper crowns 14. In some embodiments, the cutouts 76 are created for preferential forming of the collar 70. Forexample, a starting material of a round hypotube may be crushed orswaged into an oval shape to slide the collar 70 over the upper crowns14. Further, the flex sections 78 may reduce friction when the collar 70is being advanced over the struts 12. The flex sections 78 may alsominimize scraping of the collar 70 against the struts 12 of the frame 10when the collar 70 is advanced. Additionally, as best seen withreference to FIG. 7D, when the collar 70 is advanced such that the upperlocking tab 72 is engaged with the underside of an upper crown 14, thelower, inwardly biased tab 74 will help support upper tab 72 when it isadvanced into locking engagement with the upper crown 14.

FIGS. 8A through 8C illustrate another embodiment of a collar 80 thatmay be used with the various devices, systems and methods describedherein. The collar 80, also referred to as a “slider,” may have the sameor similar features and/or functionalities as the other collarsdescribed herein, and vice versa. FIG. 8A is a front view of the slideror collar 80, FIG. 8B is a side view of the collar 80, and FIG. 8C is aperspective view of the collar 80. This variation of the collar 80 isalso provided with preferential forming cut outs 86 and flex sections88, which may be similar or the same as the cutouts 76 and flex sections78 as described with reference to the collar 70 in FIGS. 7A through 7D.In this embodiment, however, locking tabs are not provided on the collar80. Rather, tabs are instead provided on the upper crown 14 (not shown)for locking engagement with cut outs 82 on the collar 80. These tabswould extend outwardly from the upper crown 14 and be downwardly biased.

FIG. 9 is a perspective view of another embodiment of a slider or collar90. The collar 90 is provided with radial locking tabs 92. Locking tabs92 are located on the sides of the collar 90 and are inwardly biased toengage with grooves (not shown) on the sides of the upper crowns 14 ofthe frame 10. Multiple levels of such grooves may be formed on the uppercrown 14, and in addition or alternatively can be provided on the upperportions of the struts 12. Such grooves in either or both locationsallow for more varied degrees of cinching of the implant 1.

FIGS. 10 through 15 are perspective views of various embodiments ofimplants that may be used with the various systems and methods describedherein. In FIGS. 10 through 15, only some of the same features may belabeled for clarity. For example, only some of the struts 12 may belabeled in the figures, etc. FIGS. 10 and 11 are perspective views of anembodiment of an implant 100. The implant 100 may have the same orsimilar features and/or functionalities as other implants describedherein, for example the implant 1, and vice versa. In particular, theimplant 100 may have the same or similar features and/or functionalitiesas the implant 1 shown in and described with respect to FIGS. 38A-59,and vice versa.

In FIG. 10, the implant 100 is shown in an embodiment of anunconstrained state. The implant 100 is shown in an embodiment of ananchored, cinched and locked state in FIG. 11. The implant 100 includesa frame 100 having struts 112, upper crowns 114, lower crowns 116 andanchors 120. These may be analogous to, for example, the frame 10, thestruts 12, the upper crowns 14, the lower crowns 16, and the anchors 20,respectively. By “analogous” it is meant these features may have thesame or similar features and/or functionalities as each other. Theimplant 100 has lower crowns 116 that are inclined at an angle withrespect to the struts 112. The lower crowns 116 may be inclined downwardand outward, or distally and outward, relative to the struts 112 and/orrelative to the axis (shown in FIG. 10). In this manner, the anchors 120may be directed more in a direction into the annular tissue above andproximate the heart valve, and less in a downward direction toward thevalve leaflets. The angle may be measured between the direction thelower crowns 116 extend and a portion of the axis extending underneaththe implant 100. The angle may also be measured between the directionthe lower crowns 116 extend and the direction that the struts 112 extenddownward. This angle may be between thirty to sixty degrees. In someembodiments, this angle is approximately forty-five degrees. The anchors120 are formed as one piece. A variety of different types of anchors maybe used with the implant 100. For example, other anchors describedherein may be used, for example the anchor 20 having the anchor head 22and anchor abutment 24, as described with respect to FIGS. 1 through 4.The implant 100 in FIGS. 10 and 11 includes opposing tab sliders orcollars 118. The collars 118 may be analogous to the collars 70,described with respect to FIGS. 7A through 7D. In some embodiments, thecollars 18 may be used that engage with a central rotating shaft 646, asfurther described for example with respect to FIGS. 38A-59.

FIGS. 12 and 13 are perspective views of an embodiment of an implant101. The implant 101 may have the same or similar features and/orfunctionalities as the implant 100, and vice versa. In particular, theimplant 101 may have the same or similar features and/or functionalitiesas the implant 1 shown in and described with respect to FIGS. 38A-59,and vice versa. In FIG. 12, the implant 101 is shown in an embodiment ofan unconstrained state. The implant 101 is shown in an embodiment of ananchored, cinched and locked state in FIG. 13. The implant 101 has uppercrowns 124 having locking tabs 130. The implant 101 also includesindexed sliders or collars 128. The collars 128 may be analogous to thecollars 80 described with respect to FIGS. 8A through 8C. The tabs 130are provided on the upper crowns 124 for locking engagement with thegrooves formed in the collar 128. Such grooves may be similar to thegrooves 82 of the collar 80.

FIGS. 14 and 15 are perspective views of an embodiment of an implant102. The implant 102 may have the same or similar features and/orfunctionalities as the implant 100 and/or 101, and vice versa. Inparticular, the implant 102 may have the same or similar features and/orfunctionalities as the implant 1 shown in and described with respect toFIGS. 38A-59, and vice versa. In FIG. 14, the implant 102 is shown in anembodiment of an unconstrained state. The implant 102 is shown in anembodiment of an anchored, cinched and locked state in FIG. 15. Theimplant 102 includes radial locking collars 148. The collars 148 may beanalogous to the collars 90, described with respect to FIG. 9. Radiallyinwardly biased locking tabs 149 on the collars 148 engage with grooves150 cut into the outer sides of the upper crowns 144. The pitch of thehelically wound anchors 120 can be varied. The pitch of the last turn ofthe anchors 120 may also be varied, for example to self-lock the anchors120 into the lower crowns 116. Moreover, the last or most distal turn ofthe helical anchors 120 may be swaged from a circular cross section to amore oval cross section to prevent backing out of the anchors 120 fromthe lower crown 116, for example to prevent backing out after engagementor anchoring in the heart tissue. Rather than swaging, pitch of the mostdistal turn of the helical anchors could be varied to prevent backingout.

FIGS. 16 and 17 are side views of a portion of an implant 103 in anun-cinched and cinched state, respectively. The views indicate anembodiment of a method for cinching the implant 103 after anchoring. Theimplant 103 may be analogous to the various implants described herein,for example the implant 1, etc. The implant 103 includes a frame 160.The frame 160 may be analogous to other frames described herein, forexample the frame 10, etc. The frame 160 has lower apices 166 whichinclude eyelets 168. A string 172 is attached to or fed through theeyelets 168. Alternatively, the string 172 can carry enlargements,knots, and the like at its ends to prevent the ends from passing throughthe eyelets 168 as the frame 160 is cinched. String 172 can be made ofwire, cable, suture, thread, or the like. Rotational member 170 iseither fixedly attached to string 172 or string 172 is passed through atunnel formed in the end of rotational member 170. FIG. 16 shows frame160 in an unconstrained state. FIG. 17 shows the frame in its implantedstate. After anchoring, the rotational member 170 is rotated therebywinding string 172 about the member 170. This action causes the gapbetween lower apices 166 to shorten thereby cinching, or reducing thediameter, of the frame 160.

FIGS. 18 and 19 show a variation of the implant 103 of FIGS. 16 and 17.In FIGS. 18 and 19, rather than have a rotational member cause thecinching, a string 180 is provided. The string 180 can take the form ofa thread, suture, or the like. The string 180 is attached to a string182 by way of loop or knot 188. The string 182 is similar to the string172 shown in FIGS. 16 and 17. FIG. 18 shows the frame 160 in anunconstrained state, while FIG. 19 shows the frame 160 being broughttowards a cinched state. As the proximal end of the string 180 is pulledby the operator to cause cinching of the frame 160, the knots 184 willclick, one by one, through an eyelet 186 in the upper crowns 187. Theknots 184 are sized so to be able to be pulled through the eyelet 186,but cannot reverse back through the eyelet 186. In this manner, theknots 184 provide a locking function and multiple degrees of cinch ofthe frame 160. After the desired degree of cinching has been achieved,the proximal ends of the string 180 are secured to maintain tension andthen cut and the ends removed from the system.

FIG. 20 is a partial side view of another embodiment of an implant 104.The implant 104 may be analogous to the other implants described herein,for example the implant 1, etc. The implant 104 includes features forcinching the frame 160. A string-like member 202 is passed throughmultiple eyelets 204 disposed on the lower apices 166. The string-likemember 202 extends circumferentially about the lower section of theframe 160. A driver unit (not shown) can be used to grab and gather thestring-like member 202 until the desired amount of reduction in thediameter of the frame 160, or cinching, is achieved. In someembodiments, other features described herein may be used with thestring-like member 202 to cinch the string-like member 202, for examplethe string 180 or the rotational member 170.

FIGS. 21A through 21D are partial side views of an embodiment of a frame210 that may be used with the various implants described herein, forexample the implant 1, etc. The views sequentially show a technique forcinching the frame 210. As shown in FIG. 21A, the frame 210 has struts212, upper crowns 214 and lower crowns 216, which may be analogous,respectively, to other struts, upper crowns and lower crowns describedherein. A central projection 218 extends downwardly from the upper crown214 into the gap or valley bounded by adjacent struts 212. The centralprojection 218 includes three tabs 220. There may be fewer or greaterthan three tabs 220. The tabs 220 extend in an upwardly oriented andangled direction, e.g. outward, from the central projection 218. Withreference to FIG. 21B, a string member 222 spans the distance betweenadjacent lower apices 216. The string member 222 may be between one,some or all distances between pairs of adjacent lower apices 216. Thestring member 222 can take the form of a wire, cable, suture, thread, orthe like. The string member 222 is passed through one or more holes 224in the lower crowns 216. The holes 224 are sized and positioned so asnot to interfere with the rotation of helical anchors 232 as they arethreadingly advanced through the holes 234 (see FIG. 21C). The anchors232 may be analogous to other anchors described herein, for example theanchors 20, etc. The ends of the string members 222 may be knotted, forexample for thread or suture string members 222. The ends of the stringmembers 222 may be provided with a weld ball, collar, etc. crimped ontoits ends, for example if the string members 222 are wire or cable. Suchend features may prevent the ends of the string members 222 from beingpulled through the holes 224 when tension is applied. As shown in FIG.21C, a driver tube 226 is operated to apply tension to pull wire 230.For ease of operation, an alignment feature 228 can be provided to alignpull wire 230 with central projection 218 and its tabs 220. Either bypulling or rotating driver tube 226, the operator applies tension topull wire 230 which is hooked around string member 222. The operator canthen apply varying degrees of cinching to frame 210 by ratcheting stringmember 222 up and into engagement with tabs 220. FIG. 21D shows theframe in one particular state of cinch. The string member 222 may beengaged with any of the tabs 220 to provide more or less cinching to theframe 210.

FIGS. 22A and 22B are perspective views of an embodiment of a distal endof a delivery catheter 40 being used to deliver an implant 1A. Thedelivery catheter 40 has various positioning and imaging capabilities.The distal end of the delivery catheter 40 is maneuvered into positionabove the heart valve annulus. The delivery catheter 40 may be used todeliver the various implants described herein, for example the implant1, etc. In particular, the delivery catheter 40 may be used to deliverthe implant 1 shown in and described with respect to FIGS. 38-59A. Theimplant 1A shown being delivered in FIGS. 22A-22B is for resizing theheart valve annulus. It is understood that a variety of differentimplants may be delivered with the delivery system and methods describedherein. The implant 1A may be analogous to the other implants describedherein, such as the implant 1. As shown, this particular implant 1Aincludes a frame 250. The frame 250 has anchors 20 attached to a loweror distal portion of the frame 250 and extending distally therefrom. Theframe 250 has an upper or proximal portion with collars 252 extendingover upper crowns 251 of the frame 250. Only some of the collars 252,upper crowns 251 and anchors 20 are labelled for clarity. The collars252 may be moved, e.g. distally, along the frame 250 by driver tubes 260to resize the frame 250. The frame 250, upper crowns 251 and collars 252may be analogous to the various frames, upper crown and collarsdescribed herein, such as the frame 10, upper crowns 14 and collars 18,and vice versa. The collars 18 may be translated axially by engagementwith the central rotating shaft 646, as further described. The anchors20 may engage with anchor housings 22A at the distal apexes, as furtherdescribed.

The frame 250, one or more driver tubes 260, and an intravascularcardiac echography (or “ICE”) catheter 270 may be extended from thedistal end of the delivery catheter 40. The frame 250 and driver tubes260 may be analogous to the various frames and driver tubes describedherein. The driver tubes 260 are shown engaging corresponding uppercrowns 252 of the frame 250. A centering frame 280 maintains concentricpositioning of the ICE catheter 270 relative to the frame 250 duringdeployment, alignment and positioning of the frame 250 above andproximate to the target heart valve annulus tissue. The centering frame280 maintains a generally centered position of the catheter 270 relativeto the frame 250. By centering the ICE catheter within the frame 250,the operator need only rotate the ICE catheter 270 to view each anchor20 and placement of the anchors 20. Further, the ICE catheter 270 couldbe used to view various other individual features of the implant 1A,such as the collars 252, for instance to view the extent to which eachcollar 252 is advanced down and over upper crowns 251 of the frame 250,to more precisely adjust the size of the frame 250. The ICE catheter 270could also provide significant benefit to an embodiment where a singularcinching mechanism or driver tube needs to be landed on each crown 251of the frame 250 to adjust the sizing of the frame 250. An indexingfeature (not shown) may also be provided on the ICE catheter 270, forexample, such that actuation of the indexing feature by the operatorcauses the ICE catheter 270 to automatically move, or rotate, to thenext anchor 20 position.

FIGS. 22C and 22D are perspective views of an embodiment of an implant1B being delivered and implanted by the delivery catheter 40. Theimplant 1B may be analogous to the various implants described herein,such as the implants 100, 101, 102, and vice versa. As shown in FIGS. 1Cand 1D, the implant 1B includes a frame 10 with struts 12 forming upperapices or crowns 14 and lower apices or crowns 16. The lower crowns 16have openings 17, such as holes, aligned to receive the anchors 20 therethrough. For clarity, only some of the upper crowns 14, lower crowns 16,struts 12 and anchors 20 are labelled in FIGS. 1C and 1D. The anchors 20may be rotated to move distally through the openings 17. The implant 1Bis intended to be delivered proximate to and above a cardiac valve(tricuspid, mitral) annulus, and subsequently implanted in the annularcardiac tissue just above the plane of the valve orifice.

Driver tubes 22′, having proximal portions 22″ extending out of thedelivery catheter 40, are provided for rotationally engaging the anchors20. Manipulation, for example rotation, of the driver tubes 22′ by theoperator causes the anchors 20 to advance towards, engage with andpenetrate cardiac tissue to secure frame 10 into the annulus approximateand above the valve. The anchors 20 may be advanced individually one ata time, some advanced together, or all advanced together. In someembodiments, the driver tube 22′ may rotate relative to the proximalportion 22″. In some embodiments, the driver tube 22′ and proximalportion 22″ are part of the same, continuous driver tube and/or theentire tube 22′ and proximal portion 22″ may rotate together.

An embodiment of an ultrasound catheter 30, such as the Acuson IPX8AcuNav catheter, is shown contained within and advanced down a centrallumen of the delivery catheter 40. The ultrasound catheter 30 may beanalogous to the ICE catheter 270. In some embodiments, by rotating theultrasound catheter 30 around the inside of the valve annulus, therelative position of the frame 10, and of any valve leaflets, will beseen for accurate positioning of the anchors 20 around and above thevalve annulus.

In some embodiments, the ultrasound catheter 30 is contained within andadvanced down an offset, non-central lumen of the delivery catheter 40.In this manner, the ultrasound catheter 30 would not interfere with theframe 10, its attachments or other features, and the driver components.In some embodiments, the ultrasound catheter 30 may be located andsteered to the side of the annulus to image, allowing for less rotationto more quickly view the anchor points of the frame 10. An offset lumencould exit more proximally with regard to the distal end of the deliverycatheter 40. This more proximal exit would reduce the overall profile ordiameter of the distal end of the delivery catheter 40. In addition,this more proximal exit port would enable a view of the valve annulusfrom above. The offset lumen could also be compressible allowing for aneven smaller profile until the ultrasound catheter 40 is advancedthrough the offset lumen.

While the ultrasound catheter 30 is shown integrated into the samedelivery system as the delivery catheter 40, in some embodiments theultrasound catheter 30 could otherwise be introduced secondarily throughanother entry site, such as through the aortic valve, and placed near orinside the implant for imaging and placement of the anchors 20.

FIG. 22E is a perspective view of an embodiment of a centering frame 32coupled to the ultrasound catheter 30 and to an implant 1C. The implant1C may be analogous to other implants described herein, such as theimplants 1, 1A, 1B, and vice versa. The centering frame 32 has centeringarms 34 connected to a centering hub 36 that is mounted on theultrasound catheter 30. As the distal end of the delivery catheter 40 ismaneuvered into position above the heart valve annulus, the centeringframe 32 maintains concentric positioning of the ultrasound catheter 30relative to the frame 10 during deployment, alignment and positioning ofthe frame 10 above and proximate to the target heart valve annulustissue. The centering aspect is desirable, for example, because if theultrasound catheter 30 remains centered within the frame 10, theoperator such as a surgeon or technician need only rotate the ultrasoundcatheter 30 to view each anchor 20 and placement the of each anchor 20.There may also be an indexing feature (not shown) on the ultrasoundcatheter 30 such that actuation of the indexing feature by the operatorcauses the ultrasound catheter 30 to automatically move, or rotate, tothe next anchor position. The centering frame 32 may be used withdelivery of the various implants described herein, such as the annulusresizing implants and/or the heart valve replacement implants.

FIG. 23 is a side view of an embodiment of an ICE catheter 270. The ICEcatheter 270 as shown includes a guidewire entry port 292 and aguidewire exit port 294 which together accept the guidewire 296. Thisembodiment allows the ICE catheter 270 to be delivered separately fromthe frame 10 thereby reducing the overall diameter of the deliverycatheter 40 (e.g. as shown in FIGS. 22A and 22B). An ICE handle may belocated at a proximal end of the catheter 270. An ICE array may belocated at the distal end of the catheter 270.

In some embodiments, a separately delivered ultrasound catheter 270could be functionally linked to the distal end of the delivery catheter40 and to the inside of the frame 10. The delivery catheter 40 couldhave mechanical docking and radiopaque features to aid in delivery andstability of the ultrasound catheter 270 relative to the deliverycatheter 40.

FIGS. 24A, 24B, 24C and 24D depict an embodiment of an ICE catheter 300that may be used with the various implants and delivery devices, systemsand methods described herein. The ICE catheter 300 has radial ultrasonictransducers 302, circumferential ultrasonic transducers 304 andguidewire 306 passing centrally therethrough. A guidewire lumen 303extends out from a delivery catheter 240. The delivery catheter 240 maybe analogous to the delivery catheter 40. The ICE catheter 300 extendsout through the guidewire lumen 303. FIGS. 24B and 24C show the implant1 deployed with the ICE catheter 300 tip. The other implants describedherein may be delivered with the ICE catheter 300, such as the implants1, 1A, 1B, 1C, and the implants 500, 520, 530 described below, etc. Inparticular, the implant 1 shown in and described with respect to FIGS.38A-59 may be delivered with the ICE catheter 300. FIG. 24C furthershows the relationship of the ICE catheter 300 to the delivery catheter240 while it is taking a radial echo view to properly position theanchor 20 for insertion into heart valve annulus tissue. FIG. 24C showsthe ICE catheter 300 capturing a circumferential echo image for properlypositioning the frame 10 in a plane above the heart valve and itsleaflets. The features shown and described in FIGS. 24A-24D may be usedto deliver various other implants, such as other resizing devices orheart valve replacement valves.

In some embodiments, software or electronic controls can be effective tocycle through the radial cross sectional images around the valve annulusperimeter, relieving the need to physically move, via rotation,translation or deflection, the ICE catheter 300. A largercircumferential transducer array could also be placed distal of theannulus to not interfere with space limitations of the delivery catheter240, further decreasing the profile of the delivery catheter 240. Inanother embodiment, the transducers of the ICE catheter 300 couldgenerate a three dimensional image of the annulus of frame 10. The usercould then more readily see the relative alignment of the annulus, valveleaflets and the implant 1.

FIGS. 25A through 25E are sequential perspective views of an embodimentof a delivery system 401 with imaging capability showing an embodimentof a method for the delivery, positioning and anchoring of the variousimplants described herein for resizing the native valve annulus. WhileFIGS. 25A through 25E depict delivery of the implant 1 for resizing theannulus, it is understood that implants for replacing the valve may alsobe delivered with the system 401. The implant 1 may be delivered,positioned and anchored to reshape the valve annulus. The implant 1 maybe inserted using the delivery system 401 via access to the vasculatureof the leg, in particular the femoral vein or the iliac vein. The system401 may include the various implants, catheters and other featuresdescribed herein, for example the implant 1, the delivery catheter 240,the ICE catheter 300, the guidewire 306, etc. The system 401 may includeany of the implants described herein, for example implants includingvalve annulus reshaping devices or valve replacements that include valveleaflets.

As shown in FIG. 25A, the system 401 is then advanced across the septumseparating the upper chambers of the heart. The ICE catheter 300 isadvanced to a position above the heart valve annulus, for example, themitral valve annulus, as shown in FIG. 25B. FIG. 25C shows the implant 1expelled from the distal end of the delivery system 401 above andproximate to the mitral valve annulus. A series of radial images aretaken to properly position the anchors 20 for insertion into the mitralvalve annulus tissue, as shown in FIG. 25D. Subsequently, acircumferential image is captured, as shown in FIG. 25E, to confirm thatall anchors 20 are appropriately placed and anchored in the mitral valveannulus tissue above the mitral valve leaflets. If one or more anchors20 are not positioned or anchored properly, they can be rotationallyretracted, repositioned and re-anchored prior to removal of the drivertubes. In addition, a circumferential image can be taken prior toanchoring to confirm location of the lower crowns 16 of the frame 10 ofthe implant 1. It should also be understood that treatment of thetricuspid valve could involve insertion of the system 401 for accessthrough the jugular vein whereby the system is then advanced down thesuperior vena cava and into the right atrium proximate and above thetricuspid valve annulus.

FIG. 26 is a perspective view of an embodiment of an implant 100 havinga constricting loop 320. The implant 100 is shown interacting with adelivery system for advancing the collars 60. The constricting loop 320may be used with other embodiments of the implant described herein, forexample the implants 101, 102, etc. In particular, the constricting loop320 may be used with the implant 1 shown in and described with respectto FIGS. 38A-59. As shown in FIG. 26, the constricting loop 320 isprovided. The constricting loop 320 encircles the frame 110 proximatethe lower crowns 16. The constricting loop may encircle upper portionsof the lower crowns 16 as shown, or other portions. A constricting loopactuator 330 may be provided to act on and constrict the constrictingloop 320. For example, the actuator 330 may include a wire with a loopthrough which the constricting loop 320 extends, and where pulling thewire proximally will constrict and tighten the constricting loop 320about the frame 110. In operation, the constricting loop 320 may beactuated first, allowing the operator to first predetermine the desireddiameter of the frame 110. The collars 60 may then be advanced, cinchingthe frame 110 and locking it in the desired diametric dimension. In someembodiments, other collars described herein may be implemented. Theconstricting loop 320 is then removed. Constricting the frame 110 alsoreduces resistance to advancement of the collars 60. Furthermore, theconstricting loop 320 assists in collapsing the frame 110 into thedistal portion of the delivery catheter. Moreover, the constricting loop320 helps reduce friction between the flared lower crowns 16 and theinner diameter of the delivery catheter. Additionally, a proximal loopcan be utilized to restrict the proximal portion of the frame 110 tochange the angle at which the anchors address the valve annulus.

FIG. 27A is a perspective view of an embodiment of an implant 105 havinga cinch loop 340. In this variation, the implant 105 does not includecollars and the cinch loop 340 is provided to cinch and lock the frameof the implant 105 in the target heart valve annulus tissue. Afteranchoring, the cinch loop 340 is tightened down by operation of a cinchloop driver 350. FIG. 27B is a detail view showing a close up view ofthe driver 350 interacting with the loop 430. The driver 350 may includean inner tube or member 351 extending therethrough to or near a distalopening of the driver 350. A distal member 352, such as a wedge, may beattached to the distal end of the inner tube 351. The distal member 352removably attaches to an element 353, for example by threadedengagement, friction fit, or other suitable engagement means. The loop340 extends through or is otherwise attached to the element 353, lockingthe loop 340 in place. Pulling the element 353 in the proximaldirection, for example by moving the driver 350 proximally, and/orpulling the inner tube 351 proximally, the loop 340 reduces incircumference around the implant 105, cinching the frame to a smallerdiameter. The ends can then be snipped and driver 350 and inner tube 351withdrawn. Once the operator has achieved the desired reduction indiameter of the anchored frame, the cinch loop 340 is locked in placeand the cinch loop driver 350 is removed. In some embodiments, the cinchloop 340 may engage with the frame 110, for example with the lowercrowns 16, to lock in place. Such engagement may be by friction fit,openings in the lower crowns 16 that allow for unidirectional movementof the loop 340, or other suitable means.

FIG. 28 is a perspective view of a delivery system 400 that may be usedto deliver the various implants described herein. In particular, thedelivery system 400 may be used to deliver the implant 1 shown in anddescribed with respect to FIGS. 38A-59. As shown in FIG. 28, thedelivery system 400 comprises a steerable sheath 402, a sheath steeringknob 404, cinch knobs 406, anchor knobs 408, the implant 100 which maybe any implant described herein, the ICE probe 270, all supported andsecured to a base 410. The cinch knobs 406 and anchor knobs 408 are allspring loaded to maintain tension. Rotation of the anchor knobs 408rotationally advance the helically wound anchors 20 into the annulartissue above the target heart valve. Cinch knobs 406 are manipulated bythe operator to advance the collars and lock the frame of the implant100 into a cinched position.

FIG. 29 is a cross section taken along line 29-29 of FIG. 28. The pullwires 412 are attached to the sheath steering knob 404 to deflect thedistal end of the sheath 402. The sheath 402 may be a steerable outersheath 402, for example made of braided polymer or metal such as Nitinolor stainless steel. The ICE catheter shaft 270 may be centrally locatedwith the guidewire lumen 303 located within the ICE catheter lumen 271.There are eight anchor driver wires 403, for example nitinol,circumferentially located within the sheath 402. The anchor driver wires403 are located within anchor driver sheaths, for example laser cuthypotubes. There are eight pusher tubes 56′, which may be braided,located around the ICE catheter shaft 270. The pusher tubes 56′ mayinclude a cinch retaining tube 404, for example a laser cut hypotube anda cinch retaining wire 407, for example nitinol.

FIGS. 30A-30C are perspective views of an embodiment of an expandablereplacement valve implant 500 shown in various states, i.e.configurations. FIG. 30A shows the replacement valve implant 500 in anunconstrained state. FIG. 30B shows the replacement valve implant 500 ina deployed and anchored state. FIG. 30C shows the replacement valveimplant 500 in an anchored and cinched state. The implant 500 may havethe same or similar features and/or functionalities as the variousimplants described herein, in particular the implant 1 shown in anddescribed with respect to FIGS. 38A-59, and vice versa. Thus the implant1 shown in and described with respect to FIGS. 38A-59 may also include areplacement valve such as with leaflets 502, etc.

The replacement valve implant 500 may be delivered with the variousdelivery systems and methods described herein. The replacement valveimplant 500 may include an associated cinching structure. Thereplacement valve implant 500 is thus suited to treat multiple diseaseconditions. For example, the replacement valve implant 500 can treatmitral regurgitation developed as a consequence of cardiomyopathy andattendant dilation of the mitral valve annulus. Moreover, thereplacement valve implant 500 and cinching structure can treat failed ordefective heart valve leaflets by replacing the native valve apparatus.Additionally, the replacement valve implant 500 and cinching structurecan treat both mitral regurgitation and those patients with concomitantdefects in the valve leaflets themselves.

The replacement valve implant 500 includes one or more non-native valveleaflets 502. The leaflets 502 may be mechanical or tissue-based such asporcine or bovine. The leaflets 502 replace the function of thedefective heart valves by providing normal or otherwise acceptable bloodflow regulation. The leaflets 502 may be configured to mimic the naturalconfiguration of native leaflets. As shown, there are three leaflets502. In some embodiments, there may be one, two, three or more leaflets502. The leaflets 502 are coupled with housing and/or other features ofthe replacement valve implant 500, as described herein. The replacementvalve implant 500 includes an inner valve housing 510.

The valve housing 510 may be a support for various features of theimplant 500, such as the leaflets 502, one or more frames, struts, etc.The valve housing 532 is configured to extend into the valve annulus andcontain the leaflets 502 therein. The leaflets 502 may be mechanicallyattached to the inner valve housing 510 by a variety of suitable means,including sutures, fasteners, adhesives, crimping, other means, orcombinations thereof. The valve housing 510 forms an inner portion ofthe replacement valve implant 500 that connects with an outer portion,as described herein. The valve housing 510 may include an inner frame508 and/or an inner barrier 519, as described herein.

The inner frame 508 may be analogous to other frames described herein,such as the frame 10, and thus be a structural member, include a tubularshape, have sinusoidal struts, etc. The inner frame 508 may be a varietyof suitable materials, such as metal, preferably nitinol. Afterdeployment from a delivery catheter and expansion to the unconstrainedshape, the inner frame 508 may or may not change shape, size, etc. Theinner frame 508 may be coupled with an outer frame 512, as describedherein. Lower apices of the inner frame 508 may be coupled with lowerapices of an outer frame 512. The inner frame 508 may be a portion ofthe outer frame 512. For example, the inner frame 508 may be part of thesame continuous structure as the frame 512 and form an inner portionthereof.

The inner frame 508 may be coupled to or otherwise carry the innerbarrier 519 to form the valve housing 510. The inner barrier 519 is amembrane-like material extending around the circumference of thevalvehousing 510. The inner barrier 519 is configured to extend into thevalve annulus to contain the leaflets 502 within the annulus. The innerbarrier 519 also acts to prevent leakage of blood flow around thereplacement valve implant 500. The inner barrier 519 may comprise any ofa variety of suitable materials, including ePTFE or a polyestermaterial, such as Dacron. The inner barrier 519 may be coupled with theinner frame 508. The inner barrier 519 may be coupled with the innerframe 508 with a variety of suitable means, for example with sutures,mechanical attachments, embedding, other suitable features, orcombinations thereof.

The inner barrier 519 may be carried by the radially inwardly oroutwardly facing surfaces of the inner frame 508. As shown, separatesegments of the inner barrier 519 may be coupled with the inner frame508 in between struts of the inner frame 508. In some embodiments, theinner barrier 519 may be a single, continuous tubular membrane. Forexample, the inner barrier 519 may be provided entirely or mostly on theinside or internal diameter of the valve housing 510. In someembodiments, the inner barrier 519 may be provided entirely or mostly onthe outside or external diameter of the valve housing 510. In someembodiments, there may be multiple barriers 519, such as an internal andan external inner barrier 519 each on opposite sides of the inner frame508.

The illustrated replacement valve implant 500 includes an outer cinchframe 512. The outer frame 512 is coupled with one or more anchors 516and one or more restraints such as collars 518. The outer frame 512,anchors 516 and collars 518 may be analogous to any of the other frames,anchors and collars described herein, for example the frame 10, anchors20 and collars 18, respectively. In particular, the collar 18 maytranslate axially due to engagement by a rotating central shaft 646,and/or the anchors 20 may engage anchor housings 22A, as furtherdescribed herein. The outer frame 512 may thus include a tubular shape,having a sidewall comprising sinusoidal or zigzag struts, withrestraints, etc. The outer frame 512 may be coupled with the inner frame508, for example at lower crowns 521 as shown. In some embodiments, theouter frame 512 may be coupled with the inner frame 508 in othermanners, such as at upper crowns, etc. In some embodiments, the innerand outer frames 508, 512 may be part of the same monolithic material,for example different portions of a single, continuous wire or laser cutframe, etc. The outer frame 512 may compress for delivery within adelivery catheter, expand upon deployment from the catheter, andcontract upon advancement of collars 518, as described herein.Contraction of the outer frame 512 may resize and/or re-shape the valveannulus. Activation of the restraints and/or manipulation of a controlsuch as a pull wire advances the proximal end of the outer frame 512radially inwardly toward the axis to reduce the inner diameter of thenative valve annulus.

The anchors 516 may be located along a proximal end of the outer frame512, as shown. In some embodiments, the anchors 516 may be in otherlocations along the circumference of the implant 500, for examplelocated farther distally, located along the distal end of the implant500, etc. The anchors 516 are inclined radially outward in the distaldirection as deployed from the head of the anchors to thetissue-penetrating tips of the anchors. In some embodiments, the anchors516 may have other orientations, for example substantially parallel tothe axis, radially outward substantially transverse to the axis,inclined in the proximal or distal directions, or combinations thereof.The anchors 516 may engage either the inner frame 508 or the outer frame512 of the implant 500, such as at a strut or apex of the outer frame512. The anchors 516 act to secure the replacement valve implant 500 totissue such that the replacement valve implant 500 extends through thenative annulus and across the native valve. The anchors 516 may behelical as described herein and rotatably engage the tissue. The anchors516 are shown retracted or pre-anchored in FIG. 30A. In FIG. 30B, theanchors 516 have been advanced into a tissue engagement orientation. InFIG. 30C, the outer frame 512 has been cinched such that the anchors 516have now pulled the valve annulus inward to reduce the circumference ofthe annulus to conform to the implant 500 and reduce or eliminate theperivalvular space.

The collars 518 may be advanced along the outer frame 512 to adjust thecircumference of the outer frame 512. The collars 518 may be advancedalong upper or lower crowns of the outer frame 512. As shown, thecollars 518 are coupled with the lower crowns 521. The collars 518 maybe advanced along the lower crowns 521 similarly as described herein,for example, with respect to the implant 1 of FIGS. 1-4, etc.

The replacement valve implant 500 may include an outer barrier 517,which may be analogous to the inner barrier 519 of the valve housing510. Thus, the outer barrier 517 of the frame 512 may be a material suchas ePTFE or polyester, and may be selected to encourage or inhibitendothelial ingrowth. The outer barrier 517 may be elastic such that itcan stretch and/or contract to reduce or prevent bunching or wrinklingof the material during and after delivery, deployment and cinching ofthe outer frame 512. The outer barrier 517 may be carried on theradially inwardly or outwardly surface of the outer frame 512. As shown,separate segments of the outer barrier 517 may be coupled with the frame512 in between struts of the outer frame 512. In some embodiments, theouter barrier 517 may be a single, continuous membrane. For example, theouter barrier 517 may be provided on the inside or internal diameter ofthe outer frame 512. In some embodiments, the outer barrier 517 may beprovided on the outside or external diameter of the outer frame 512. Insome embodiments, there may be multiple barriers 517, such as aninternal and external outer barrier 517. In some embodiments, there maynot be any barrier 517.

The outer frame 512 and/or barrier 517 may form a generallyfrustoconical shape in the unconstrained state, as shown in FIG. 30A.Thus, the struts of the outer frame 512 and the barrier 517 are inclinedoutward in the proximal direction relative to the longitudinal axis ofthe replacement valve implant 500. The proximal edge of the barrier 517is located radially farther outward relative to the distal edge of thebarrier 517 in the unconstrained state. The outer frame 512 and/or outerbarrier 517 may contact various portions of the native heart anatomyafter deployment from the delivery catheter, such as the annulus wall.After the anchors 516 have engaged the tissue but before cinching theouter frame 512, the outer frame 512 and/or outer barrier 517 may stillbe in a generally frustoconical shape, as shown in FIG. 30B, leaving aperivalvular annular space but blocking perivalvular blood flow by theouter barrier 517 and/or inner barrier 519. After cinching the outerframe 512, the outer frame 512 and/or outer barrier 517 may form agenerally cylindrical shape, as shown in FIG. 30C. In some embodiments,after cinching the outer frame 512, the outer frame 512 and/or outerbarrier 517 may form other shapes, such as a generally frustoconicalshape, other non-cylindrical shapes, etc.

The replacement valve implant 500 shown in FIGS. 30A-30B includes anannular atrial skirt or flange 514. The atrial flange 514 may be anextension of the barrier 517 in the radial or generally radial directionfor at least about 2 mm, or about 5 mm, or more. The atrial flange 514extends outward from a proximal edge of the outer frame 512. In someembodiments, the atrial flange 514 may instead extend outward from adistal edge of the outer frame 512, for example forming a “ventricular”flange situated inside the annulus and/or within the left ventricle (fora mitral valve implant). Such “ventricular” flange may be analogous tothe atrial flange 514 as described herein. The atrial flange 514 and/orother flanges may further reduce and/or prevent of leakage of blood flowaround the replacement valve implant 500, e.g. leakage in between thereplacement valve implant 500 and the surrounding valve annulus. Theatrial flange 514 may be a variety of suitable materials, such as ePTFEor a polyester material, for example Dacron. The atrial flange 514 maythus be a similar material as the outer barrier 517. In someembodiments, the atrial flange 514 may also include an extension of theouter frame 512 in the outward direction and providing support for thebarrier material, such as the polyester material.

FIG. 30B shows the replacement valve implant 500 in its deployed andanchored state. As shown, the anchors 516 have been advanced through andengage the frame 508 and through the flange 514 and into tissue. Holes503 are provided in or adjacent to the atrial flange 514 to allow thehelically wound anchors 516 to pass therethrough and anchor into theannular tissue above the heart valve. The anchors 516 may also fixedlyengage the flange 514. The anchors 516 may engage the atrial flange 514such that a fixed connection is provided between the flange 514 and therespective anchor 516 before and/or after advancement of the anchors 516therethrough. The flange 514 has a generally annular shape around thecircumference of the implant 500. The flange 514 may be generallycircular, or other rounded or non-rounded shapes. The flange 514 maybesymmetric or asymmetric with respect to the axis or with a plane thatincludes the axis

The replacement valve implant 500 may have a variety of suitabledimensions. In the deployed and anchored state, and/or the deployed andunanchored state, and/or in the anchored and uncinched state, and/or inthe anchored and cinched state, the valve housing 510 may have a heightmeasured along the axis 513 in the range of about twenty millimeters toabout thirty millimeters, although such height can vary. In someembodiments, in these various states the valve housing 510 may have aheight in the range of about ten millimeters to about fifty millimeters.Referring to FIGS. 30A-30B, the inner diameter 511 of the valve housing510 may be within the range of about twenty-five millimeters to aboutthirty millimeters, although such diameter can be varied. In someembodiments, the inner diameter 511 of the valve housing 510 may bewithin the range of about fifteen millimeters to about sixtymillimeters. Referring to FIG. 30B, the atrial flange 514 may have aradial width 515 between about five millimeters and about thirtymillimeters. In some embodiments, the atrial flange 514 may have a width515 between about ten millimeters and about twenty millimeters wide.Referring to FIG. 30C, depending on the disease state(s), the cinchframe 512 can have an outer diameter 523 from about forty millimeters toabout eighty millimeters. Larger diameters may be implemented, forexample, if the disease state is or includes a dilated heart valveannulus as incidence of the patient's cardiomyopathy. The inner diameter525 of the cinch frame 512, which may be measured in some embodimentsfrom anchor 516 head to opposite anchor 516 head, may range from aboutthirty millimeters to about sixty millimeters, or in some embodimentsfrom about fifteen millimeters to about one hundred millimeters, in thecinched orientation.

After the replacement valve implant 500 is anchored in place, it iscinched as shown in FIG. 30C. Cinching may be accomplished by a cinchingmechanism on the deployment catheter, followed by advancing the collars518 to achieve retention. Alternatively, cinching may be accomplished bymanipulation and movement of collars 518. The various cinchingtechniques described herein may be employed. The replacement valveimplant 500 may encourage tissue ingrowth after implantation. Forexample, the inner our outer frame 508, 512, the inner barrier 519, theouter barrier 517, other features of the implant 500, or combinationsthereof, may be configured to facilitate tissue ingrowth and furthersecurement of the implant 500 within the heart.

FIG. 31 illustrates the replacement valve implant 500 positioned,anchored, cinched and implanted in the annular tissue above andproximate the target heart valve. For illustration purposes, thereplacement valve implant 500 has been deployed across the native mitralvalve, with the atrial flange 514 blocking or at least substantiallyblocking paravalvular leakage around the replacement valve implant 500.The replacement valve implant 500 is in sealing engagement with theatrial wall surrounding the native valve, which in some embodiments maybe due in part to atrial blood pressure.

While the atrial flange 514 provides additional sealing in the atrium,in some embodiments such additional sealing may not be included. FIGS.32A and 32B are perspective views of embodiments of heart valvereplacements 520 and 520′ without the additional sealing or atrialflange 514 and shown, respectively, in an unconstrained state and in acinched state. Further, the heart valve replacement 520 includes theouter barrier 517 located on the outside of the outer frame 512, whilethe heart valve replacement 520′ includes the outer barrier 517 locatedon the inside of the outer frame 512. The heart valve replacements 520and 520′ may otherwise be analogous to the heart valve replacement 500.Like reference numerals with respect to FIGS. 30A through 30C thusrepresent like elements in FIGS. 32A and 32B. After being anchored inposition as shown in FIG. 32A, the collars are actuated, in a mannersimilar to that of FIG. 30C, to cinch the replacement valve 520 as shownin FIG. 32B. While nine anchors 516 have been shown with respect to thereplacement valve embodiments of FIGS. 30 through 32, it is understoodthat the number of such anchors 516 can be varied. In some embodiments,such variance of the number of anchors 516 can range from three toeighteen. In some embodiments, the number of anchors 516 can vary inmultiples of three.

Another embodiment of a replacement valve implant 530 is depicted inFIGS. 33A and 33B. FIG. 33A shows the replacement valve implant 530 inan unconstrained and unanchored state and FIG. 33B shows the replacementvalve implant 530 in an anchored, cinched and locked state. Thereplacement valve implant 530 may include features analogous to featuresdescribed with respect to other implants herein, for example the implant1, 500, 520, 520′, etc., and vice versa. In particular, the replacementvalve implant 530 may include features analogous to features describedwith respect to the implant 1 shown in and described with respect toFIGS. 38A-59, and vice versa.

The replacement valve implant 530 includes an inner valve housing 532and an outer frame 536. The valve housing 532 may be analogous to thevalve housing 510. The valve housing 532 may include one or moreleaflets 502, which may be analogous to the leaflets 502 as describedwith respect to the replacement valve implant 500. The valve housing 532may include an inner frame 535 as shown, which may be formed of nitinol.The inner frame 535 may thus have proximal, generally diamond-shapedsegments that are adjacent distal, irregular hexagonal-shaped segmentsextending circumferentially in a generally tubular shape about an axis,as indicated in FIG. 33B. The valve housing 532 has a series of uppercrowns 542 with openings therethrough. The openings may be circular orother shapes. The openings in the upper crowns 542 may engage with oneor more features of an outer cinch frame 536, such as extensions 540that extend from upper crowns of the outer frame 536.

The outer frame 536 may be analogous to other frames or outer framesdescribed herein, for example, the frames 10, 512, etc. The outer frame536 is coupled with one or more anchors 516 and one or more restraintssuch as collars 518. The outer frame 536 may be coupled with the valvehousing 532, for example the inner frame 535, at the upper (proximal)crowns 542, as described. In some embodiments, the outer frame 536 maybe coupled with the inner frame 535 in other manners, such as at lowercrowns, etc. In some embodiments, the inner and outer frames 535, 536may be part of the same monolithic material, for example differentportions of a single, continuous frame, etc.

The outer frame 536 may compress for delivery within a deliverycatheter, expand upon deployment from the catheter, and contract uponadvancement of collars 518, as described herein. The outer frame 536 inan unconstrained state, as shown in FIG. 33A, inclines radially outwardin a distal direction from a proximal end of the valve housing 532.Contraction of the outer frame 536 to a cinched state, as shown in FIG.33B, may resize and/or re-shape the native valve annulus. The outerframe 536 may advance radially inwardly toward the axis to reduce theinner diameter of the native valve annulus into conformance with theinner frame 535. The outer frame 536 may include collars 538 at theupper crowns 534. The collars 538 may be advanced distally to cinch theimplant 530 to cause the outer frame 536 to advance radially inward. Thecollars 538 may interact with the outer frame 536 to cinch the outerframe 536 as described herein with respect to other collars and frames,such as the collars 18 and the frame 10, etc.

The extensions 540 include perpendicularly disposed tabs generallyforming T-Bar extensions on the upper crowns 534 of the outer frame 536.The extensions 540 engage with the openings in the upper crowns 542 ofthe valve housing 532 to pivotally secure the outer frame 536 to thevalve housing 532. The extensions 540 may be inserted into the openingsduring assembly of the replacement valve implant 530. The anchors 516are moveably engaged with lower crowns 521 that are located in betweenupper crowns 542 of the valve housing 532. The anchors 516 may engagewith the lower crowns as described herein with respect to other anchorsand crowns, such as the anchors 20 and lower crowns 16, etc. After theanchors 516 have been rotationally advanced into the annular heart valvetissue, cinching of the outer frame 536 as shown in FIG. 33B will drawthe annular tissue or portions thereof toward the valve housing 532.Further, in the cinched state shown in FIG. 33B, portions of the nativeannulus tissue may be drawn radially inward and/or upward (proximally)in between the outer frame 536 and the valve housing 532. This actionwill reduce the potential for paravalvular leaking and migration of thereplacement valve implant 530. In some embodiments, the valve housing532 may be tapered, for example having a smaller diameter on the atrialside of the valve orifice and a larger diameter on the ventricular sideto facilitate blood flow through and across the replacement heart valve530.

Relatively large diameter catheter shafts are described herein that maybe used to deliver the re-sizing implants, such as the implant 1 andothers, or valve replacements, such as the valve 500 and others, asdescribed herein. These large diameter catheter shafts may includefeatures that mitigate or eliminate the tendency to kink, wrinkle ortear when attempting a sharp bend radius. FIGS. 34A through 37 showvarious embodiments of sections of steerable catheters that may be usedwith the various implants described herein. The features of thesteerable catheters improve the catheter's ability to maneuver tightbends to a position above and proximate and/or into the mitral valveannulus or tricuspid valve annulus.

FIGS. 34A and 34B are side views of an embodiment of a distal section600 of a steerable catheter 602 shown in straight and flexed states,respectively, that may be used to deliver the various implants describedherein. In particular, the steerable catheter 602 may be used to deliverthe implant 1 shown in and described with respect to FIGS. 38A-59. Thesteerable catheter 602 may be used in the various delivery systems andmethods described herein. As shown in FIGS. 34A-34B, the steerablecatheter 602 may have a distal end 604 and intermediate section 606. Thedistal end 604 may be a deflectable section, as described herein. Thedistal end 604 may include a length of the catheter 602 extending fromthe distal tip. For example, the deflectable section of the distal end604 may include a length of five or ten or fifteen centimeters, or moreor less, of the catheter 602 as measured from the distal tip in aproximal direction. The intermediate section 606 may take the form of ashaft section reinforced with a braid or slotted tubing. The catheter602 may include a proximal end opposite the distal end 604. Only aportion of the catheter 602 is shown for clarity. The proximal end ofthe catheter 602 may be coupled with a proximal manifold having adeflection control. The catheter 602 and/or features thereof may beimplemented with the various catheters and delivery systems describedherein, for example those shown in and/or described with respect toFIGS. 22A-25E, or others.

FIGS. 35A and 35B depict an embodiment of the distal section 604 thatmay be used with the steerable catheter 602, shown in straight andflexed states, respectively. The distal section 604 has a single spine608 running along its outer curve, and a series of support ribs 610formed or cut into the inner curve. The distal section 604 may be formedof a flexible metal tube, such as nitinol. The distal section 604 mayincorporate pull wires for control of the delivery system.Alternatively, the pull wire may be looped around the distal section'sdistal tip and back toward the proximal part of the catheter 602. Thesupport ribs 610, with voids therebetween, allow the distal section 604to achieve a tight bend radius. This flexed state of the distal section604 is realized with minimal protrusion of the support ribs 610 into theinner diameter or outer diameter of the distal section 604. Moreover,the spine 608 provides a smooth surface on the outer curve of the distalsection 604 minimizing friction or interference with heart tissue duringdelivery and positioning of the catheter and implant.

FIGS. 36A and 36B illustrate another embodiment of a distal section 614that may be used with the steerable catheter 602. Here, the distalsection 614 may be a flexible metal tube that is wrapped or encased in athin film 612 or polymeric material such as Teflon, pTfe, nylon or otherthin material. This thin film 612 encapsulation does not restrict theflexibility of the distal section 614 but does provide for smootherdelivery and transition into and out of a guide catheter. The thin film612 may be stretchable or designed to fold in on itself, somewhatsimilar to an accordion, when flexed as shown in FIG. 36B.

FIG. 37 shows another embodiment of a distal section 624 that may beused with the steerable catheter 602. Here, distal section 624 comprisesa series of larger elements 626 and smaller elements 628. The smallerelements 628 nest within the larger elements 626. All elements may slideover one another. When the distal section 624 is in a straight state,the metal elements are most overlapped. As the distal section 624 isactuated towards the flexed state, as shown for example in FIG. 37,there may be progressively less overlap of the elements particularly onthe outer curve of the distal section 624.

The embodiments of the distal and intermediate sections of the catheter602 are intended for use in the delivery and implant of both thering-like embodiments and the replacement valve embodiments describedherein. In treating the mitral valve, for example, once the catheter ispassed through the septum separating the right and left atria, it isguided slightly upwardly towards the upper reaches of the left atrialchamber. It is then bent significantly in a direction downward towardsthe mitral annulus, aligning the distal end and the implant with themitral annulus. The devices, systems and methods described herein allowsuch bending to occur without kinking or wrinkling which would otherwiseimpede delivery of the implant.

FIGS. 38A-59 show embodiments of implants having features for advancing,for example driving, translating or otherwise moving, a retention slideror collar 18 over a corresponding pair of adjacent struts 12. Thefeatures described with respect to FIGS. 38A-59 may be used with otherimplants, delivery systems, etc. as described herein, and vice versa.The various embodiments of the implant 1 described with respect to FIGS.38A-59 may have the same or similar features and/or functionalities asother embodiments of the implant 1 or other implants described herein,such as the implants 1A, 1B, 1C, 100, 101, 102, 103, 104, 105, 500, 520,520′, 530, and vice versa. The implant 1 of FIGS. 38A-59 may operativelycouple with, or be configured to operatively couple with, a valve orvalve leaflets for complete valve replacement. Such valve replacementmay also include annulus reshaping.

FIG. 38A is a perspective view of an embodiment of the implant 1 havinga proximal end 2 and a distal end 4 with a central lumen extendingtherethrough along the axis as indicated. The implant 1 may beconfigured for catheter-based delivery. In treating the mitral valve,for example, a delivery catheter is inserted via a puncture in thefemoral vein, after which it traverses the inferior vena cava, into theright atrium and passes through the septum separating the right and leftatria. It is then directed distally towards the mitral annulus, aligningthe distal end of the catheter and the implant 1 with the mitralannulus.

The implant 1 is shown having the frame 10 with rotatable shafts 646 andaxially translatable collars 18 at the proximal apexes 14. The proximalend of the rotatable shafts 646 each include a coupling 660 forengagement and rotation by a driver or adjustment catheter to rotate theshaft 646. As further describe herein, rotation of the shaft 646 causesthe collar 18 to advance along the struts 12 to change, e.g. increase ordecrease, the angle between the struts 12 to radially contract or expandthe implant 1. Each distal apex 16 includes the helical anchor 20engaged with openings 17 of the corresponding distal apex 16. Eachanchor 20 includes a proximal portion 26B and a distal portion 26C. Onthe proximal end of the proximal portion 26B is a coupling 24D. Thecoupling 24D may be engaged and rotated by a driver or adjustmentcatheter to rotate the anchor 20 through the openings 17 and intotissue. Each coupling 660 and 24D may be engaged and rotated by its owndriver or adjustment catheter. Thus, there may be such a driver for eachcoupling 660, 24D. The collars 18 and anchors 20 are shown in a relativeproximal position and may be adjusted proximally or distally therefromto effect various changes in the frame 10. The implant 1 of FIG. 38A andits various features are described in further detail herein. The implant1 of FIG. 38A may have any of the same or similar features and/orfunctionalities as any other implant described herein, including but notlimited to the implant 1 of FIG. 47, and vice versa.

FIG. 38B depicts a partial flattened side view of the embodiment of theimplant 1 shown in FIG. 38A. As shown in FIG. 38B, the implant 1 has anembodiment of the frame 10 with an axially translatable collar 18 and arotatable threaded shaft 646. For clarity, only one collar 18 and twoshafts 646 are shown. There may be more collars 18 and shafts 464, forexample one collar 18 and one shaft 646 located at at least two or threeor four or at each proximal apex of the frame 10. The threaded shaft 646is located, for example nested, secured, retained, etc., within aportion of the frame 10 and located internally to the collar 18. In someembodiments for driving the collar 18 over an apex formed by a pair ofadjacent struts 12, the threaded shaft 646 may be rotated internally tothe collar 18. Rotational motion of the threaded shaft 646 istransmitted from external engagement features, such as threads, of thethreaded shaft 646 to corresponding internal features, such as internalthreads or teeth, of the collar 18, to result in axial movement of thecollar 18. As the collar 18 moves distally, it causes adjacent struts 12to move closer together, decreasing the angle C (as shown for example inFIG. 44C) between the struts 12, and causing the implant 1, for examplethe frame 10, to reduce in width, e.g. diameter. The collar 18 mayremain or substantially remain rotationally stationary relative to thestruts 12. Thus, for example, the threaded shaft 646 may be rotatedwhile remaining axially stationary and the collar 18 may translateaxially while remaining rotationally stationary or substantiallyrotationally stationery. By “substantially rotationally stationery” itis meant that the collar 18 may rotate some amount after which furtherrotational movement is prevented, for example due to play between thecollar 18 and the struts, as further described.

These are general principles of the retention features for the implant 1that are described in further detail herein. Various modifications maybe implemented. For example, in some embodiments, the threaded shaft 646may axially translate. In some embodiments, the collar 18 may rotate. Insome embodiments, the collar 18 may be rotated and move axially, whilethe threaded shaft 646 remains rotationally and axially stationary. Themechanical communication between outer threads of the threaded shaft 646and the inner features (such as threads) of the collar 18 may be directcommunication, such as contact between the respective threads andfeatures. In some embodiments, the mechanical communication may beindirect, for example with intervening structures such as bushings andthe like, coatings, etc. in between the respective engagement features.These and other modifications to the implant 1 that are still within thescope of the disclosure will be apparent in light of the further detailsand description herein.

As further shown in FIG. 38B, there is illustrated a partial view of theframe 10 extending between a proximal end 2 and a distal end 4. Theframe 10 may form a tubular shape, as described herein, for example withrespect to FIG. 38A or FIG. 1. A plurality of the struts 12 extendbetween proximal apexes 14 and distal apexes 16, as has been discussed.The distal apex 16 may be provided with an anchor mount such as aplurality of apertures 17 for receiving helical anchors (such as theanchors 20, shown for example in FIGS. 44A-44C). In some embodiments,the distal apex 16 may include “reach” anchor features such as ahousing, for example as described with respect to FIGS. 47A-59. Oneadjacent pair of struts 12A and 12B carry the collar 18. The collar 18may be included on more than one or all of the proximal apexes 14 formedby corresponding pairs of adjacent struts 12. For clarity, some featuresare not shown on some of the proximal apexes 14.

In some embodiments, the proximal apex 14 may include features to carrythe shaft 646 and/or collar 18. As shown, at least one proximal apex 14is provided with at least a first support 630. The first support 630 mayextend in a proximal direction from the corresponding strut 12. In theillustrated embodiment, a second support 632 is additionally provided,spaced apart from the first support 630. The first and second supports630, 632 are structural members extending proximally from the apex 14.The first and second supports 630, 632 may have square or rectangularcross-sections, or other shapes. The first and second supports 630, 632may be integral with the apex 14 or may be separate parts attachedthereto. The first and second supports 630, 632 may have the same orsimilar radial thickness as the apex 14 and/or struts 12, and all may belaser cut from a single metal (e.g., stainless steel) tube. The firstand second supports 630, 632 may at least partially form a window 634therebetween. The window 634 is a space or opening between the supports630, 632. The window 634 may have a generally rectangular shape asshown, or it may be square, rounded, or other shapes. The window 634 maybe partially formed by other features of the frame 10, as furtherdescribed.

The first support 630 is provided with a first medial flange 636 and thesecond support 632 is provided with a second medial flange 638. Thefirst and second medial flanges 636, 638 may be integral with the firstand second supports 630, 632, respectively, or may be separate partsattached thereto. The first and second medial flanges 636, 638 extendinwardly. The flanges 636, 638 extend towards a rotation axis of thethreaded shaft 646. The flanges 636, 638 extend generallycircumferentially.

The flanges 636, 638 are separated from each other by a central aperture640. The aperture 640 is an opening or space located between the flanges636, 638. In some embodiments, there may not be any flanges 636, 638, orthe flanges 636, 638 may not extend inwardly toward the rotation axis,and the apertures 640 may thus be a space between the first and secondsupports 630, 632. The first and second medial flanges 636, 638 maypartially form a proximal portion of a frame defining the window 634.The window 634 may be open to the aperture 640. A continuous space maybe formed that extends from the window 634 to the aperture 640 and thatopens to a proximal side of the frame 10.

In some embodiments, the flanges 636, 638 may be connected and form acontinuous bridge along the proximal end of the window 634 that has theaperture 640 therethrough. For example, the proximal ends of the firstand second supports 630, 632 may be connected by a circumferential crossmember that includes the aperture 640 as a hole extending axiallytherethrough. In such embodiments, the shaft 646 may be radiallyinserted into the window 634 and a proximal post or coupling may beaxially and distally inserted through the aperture 640 to attach to theshaft 646.

As shown, the first medial flange 636 provides a distally facing bearingsurface 642, which may have an undercut 644, as will be discussed. Thesecond medial flange 638 may also be provided with the bearing surface642. For clarity, only some of the features at or around each proximalapex 14 shown in FIG. 38B are labelled, for example the medial flanges636, 638, central aperture 640, bearing surface 642, undercut 644, etc.It is understood that the implant 1 may include these and other featuresin other locations, for example other apexes 14, even if not explicitlylabelled in the figure. The bearing surface 642 may be a structureagainst which features of the shaft 646 may contact. The bearing surface642 may have a topography that complements that of the shaft 646 orfeatures thereof. The bearing surface 642 may be curved or rounded asshown. The bearing surface may be circumferentially rounded toaccommodate, retain and guide an adjacent and complementary rotatingsurface of the shaft 646. The bearing surface 642 may be smooth orgenerally smooth. In some embodiments, the bearing surface 642 mayinclude locking features, such as rough surface portions, proximallyextending or angled tabs, or other features that prevent unwantedrotation by the shaft 646 and corresponding unwanted distal movement ofthe collar 18, for example after implantation. These various shapes andfeatures may be formed or defined by the undercut 644 of the bearingsurface 642.

The threaded shaft 646 may be an elongated structural member extendingalong an axis thereof. The threaded shaft 646 may be cylindrical. Insome embodiments, the threaded shaft 646 may have other shapes, or bepartially cylindrical, etc. The width of the threaded shaft 64 may beconstant along all or a portion of the elongated length thereof. In someembodiments, the width may not be constant. The threaded shaft 646 maybe solid, hollow, partially solid, or partially hollow. The threadedshaft 646 may be formed of stainless steel, cobalt-chromium, titanium,other implant grade materials, polymers, plastics, alloys, othersuitable materials, or combinations thereof.

The threaded shaft 646 may have external engagement features such asouter threads 647. For clarity, only some of the threads 647 arelabelled in FIG. 38B. The threads 647 may be one continuous threadextending helically around the shaft. In some embodiments, the threads647 may be discontinuous. The threads 647 may be helical externalridges, for example wrapped around a central cylinder. The threads 647may extend entirely or partially along the outside surface of thethreaded shaft 646 from or between a distal end and a proximal endthereof. At one or both ends of the threads 647, the thread may beincomplete, for example a tab extending less than a full revolutionabout the shaft. The threaded shaft 646 may be similar to a screw orthreaded fastener, such as an externally-threaded rotating screw member.The threads 647 may be cut, rolled, or formed by a variety of suitabletechniques.

The threads 647 may have a variety of different pitches and inner/outerdiameters. The threaded shaft 646 may have one or more portions havingan external thread 647 measuring from about 0.010 to about 0.090 inchesin diameter, from about 0.020 to about 0.080 inches in diameter, fromabout 0.030 to about 0.070 inches in diameter, or from about 0.040 toabout 0.060 inches in diameter, or other amounts or ranges. Thisdiameter may be an outer diameter as measured from peak to opposite peakof the threads 647. The threaded shaft 646 may have from about 10 toabout 150 threads per inch, from about 20 to about 140 threads per inch,from about 30 to about 130 threads per inch, from about 40 to about 120threads per inch, from about 50 to about 130 threads per inch, fromabout 60 to about 120 threads per inch, from about 70 to about 110threads per inch, from about 80 to about 100 threads per inch, or otheramounts or ranges. In some embodiments, the threaded shaft 646 has aportion having an external thread measuring from about 0.040 to about0.060 inches in diameter and from about 60 to about 120 threads perinch. The pitch and inner/outer diameters of the threads 647 maycomplement that of corresponding internal engagement features, such asthreads or teeth, of the collar 18.

The threaded shaft 646 may be located, for example carried or retained,at the proximal apex 14. The threaded shaft 464 may be retained at leastpartially in the corresponding window 634. The threaded shaft 646 may bemostly retained within such window 634. The threaded shaft 646 is freelyor substantially freely rotatable about its rotation axis but isconstrained or substantially constrained against axial and/orcircumferential movement. The shaft 646 may extend circumferentiallybetween the first and second supports 630, 632. The shaft 646 mayextend, for example protrude, radially inward and/or outward beyond thefirst and second supports 630, 632.

In some embodiments, “axial” as applied to axial movement or restraintof the threaded shaft 646 or collar 18, or other features carried by anapex of the implant 1, includes directions that are at least partiallyin the proximal or distal direction and that are parallel or generallyparallel to a plane containing a corresponding pair of adjacent struts12, such as the struts 12A, 12B and/or a plane containing the apex 14.Thus axial may be in a proximal or distal direction along the apex 14 oralong a plane defined by a pair of adjacent struts 12. This directionmay or may not be parallel or generally parallel to the central axis ofthe implant 1. For instance, in some embodiments, the struts 12 may“flare” or incline radially inward or outward, as further described,such that the collar 18 may move in an “axial” direction that is notparallel to a central longitudinal axis of the implant 1 (for example,see the central longitudinal axis shown in FIG. 1). Thus, “axial”movement of the collar 18 may refer, in some configurations or duringportions of the anchoring procedure, to a direction parallel to thelongitudinal axis of the implant 1, and in other configurations orduring other portions of the anchoring procedure to a direction that isnot parallel to the longitudinal axis of the implant 1. The axialdirection of movement of the collar 18 may change relative to thelongitudinal axis of the implant 1 as the implant 1 changesconfigurations, for example cinches and reduces width. Further detailsof “flaring” of the implant 1 are provided herein, for example withrespect to FIG. 44.

Referring to FIG. 38B, the threaded shaft 646 may interact with variousfeatures of the window 634, which may be formed by various features ofthe implant 1. The threaded shaft 646 extends between the bearingsurface 642 and a distal bearing surface 648 carried by the proximalapex 14. The bearing surface or surfaces 642 and the distal bearingsurface 648 may form, respectively, proximal and distal boundaries ofthe window 634. The threaded shaft 646 may be provided with a ridge 650.The ridge 650 may be an annular piece, and may be proximally facing. Theridge 650 may be integral with the threaded shaft 646, or a separatepiece attached thereto. The ridge 650 is one option and other suitableproximal end features may be implemented, as described herein, forexample with respect to FIG. 40A. As shown in FIG. 38B, the ridge 650may have a proximal surface or surfaces 651. The surface 651 may be acomplementary surface to the undercuts 644 of the corresponding medialflanges 636, 638. The surface 651 may contact the medial flanges 636,638, for example the bearing surfaces 642 of the undercuts 644. In FIG.38B, for clarity one of the ridges 650 (on the left as oriented in thefigure) is shown backed off from the corresponding undercut 644, suchthat a gap exists. The surface 651 may help maintain centration of theshaft 646 during rotation of the threaded shaft 646. The surface 651 maymaintain the axial location and/or alignment of a proximal end of thethreaded shaft 646.

The distal end of the threaded shaft 646 may be provided with featuresto maintain alignment of the threaded shaft 646. In some embodiments,the threaded shaft 646 may be provided with a distally facing membersuch as a post, a proximally extending recess, etc. to engage acomplimentary surface structure such as a post or recess on the apex 14,such as at or in the distal bearing surface 648, to enable rotationalalignment between the threaded shaft 646 and the apex 14. An embodimentof additional example features for the distal end of the threaded shaft646 is shown in and described with respect to FIG. 40A, which featuresmay in addition or alternatively be included with the threaded shaft 646as shown in FIG. 38B.

One or more coupling features may be located at a proximal region of thethreaded shaft 646 to transmit rotational torque to the shaft 646, andin some embodiments transmit longitudinal push/pull forces to the shaft646. In some embodiments, the threaded shaft 646 may be rotated by aproximal member 655, such as a post, protrusion, projection, etc. Thefeature may be a coupling 660 (see FIGS. 40A, 41-43) which may interactwith a corresponding coupling 666 from a delivery system 680 (see FIG.40B) that could be disconnected from the implant 1, e.g. from featuresof the threaded shaft 646 such as the coupling 660, for permanentimplantation of the implant 1 in the body. In some embodiments, theproximal member 655 may be attached to the coupling 660 or otherfeatures for transmitting rotation. In some embodiments, the coupling660 may attach to or replace the proximal member 655. The threaded shaft646 may thus be nested internal to the frame 10 and may be rotated viathe proximal member 655 and/or coupling 660 by a delivery system, forexample by allowing a cut pattern to accept or otherwise couple with theproximal member 655 and/or coupling 660 of the threaded shaft 646, asfurther described. The proximal member 655 and/or coupling 660 may havea maximum width that is less than a maximum width of the threaded shaft646, such that a moment arm for a required applied torque is minimized,as further described.

Thus, the threaded shaft 646 may be allowed to rotate within the window634 and be driven from the proximal member 655 and/or coupling 660proximal to the frame 10, through a rotating delivery system membercoupled to the threaded shaft 646 via the proximal member 655 and/orcoupling 660. The proximal member 655 and/or coupling 660 thus allow forrotational motion to be transmitted from external the implant 1, forexample by the surgeon through a catheter, and also allow atranslational motion for implant 1 positioning. The plurality of theseconnections would allow for an angulation of the implant 1 in the leftatrium during anchor placement. Further detail of the coupling 660 anddelivery and anchoring aspects are provided herein, for example withrespect to FIGS. 40A-44.

Variable axial positioning of the collars 18 may be used for deliveryand controlled radial expansion and/or contraction of the implant 1during implantation and before anchoring to tissue. The collars 18 maybe initially advanced in a position that is distal to a proximal-mostposition of the collar 18 along the struts, to restrain the implant 1 ina delivery configuration for delivery in a delivery catheter. Once theimplant 1 is positioned in the atrium and exposed (e.g., a distal sheathover the implant 1 is removed), the collars 18 may be advancedproximally to allow radial expansion of the implant 1 to an anchoringconfiguration for anchoring to the annulus. Before or after the implant1 is positioned adjacent to the annulus for anchoring, the collars 18may be adjusted as needed to obtain the desired size and shape prior toanchoring to tissue. After the implant 1 is anchored, the collars 18 maythen be advanced distally to radially contract the implant 1 andannulus. Thus, the collars 18 may also assist with achieving variousdelivery and anchoring configurations and adjustment of the implant 1.In some embodiments, alternatively or in addition to the collars, otherfeatures may provide such functions, such as features of the deliverysystem.

FIG. 39 is a partial perspective view of one of the proximal apexes 14of the implant 1 showing one of the collars 18 interacting with thecorresponding threaded shaft 646. One or more of the proximal apexes 14may include one or more of the collars 18. In some embodiments, eachproximal apex 14 includes one collar 18. There may be eight proximalapexes 14, each carrying a respective collar 18 and shaft 646 (i.e.eight collar 18 and eight shafts 646). In some embodiments, there may beless than or more than eight each of the proximal apexes 14, collars 18,and shafts 646. There may be one, two, three, four, five, six, seven,nine, ten, eleven, twelve, or more of each of the proximal apexes 14,collars 18, and shafts 646. In some embodiments, one or more of thedistal apexes 16 may, in addition or alternatively, include one or moreof the collars 18. For example, the various features described withrespect to the threaded shaft 646 and collar 18, etc. located at theproximal apexes 14 may in some embodiments be located at distal apexes17.

The collar 18 may have a generally rectangular shape. The cross-sectionmay be rectangular. In some embodiments, the collar 18 may be square,rounded, contoured, other suitable shapes, or combinations thereof. Thecollar 18 may be constructed of an implant material such as stainlesssteel, cobalt chromium, titanium, nickel-titanium or polymers such asPEEK, plastics, other implant grade materials, or combinations thereof.The collar 18 may be formed by extrusion or other suitable techniques.The axial length may be from about 2 millimeters to about 16millimeters, from about 3 millimeters to about 14 millimeters, fromabout 4 millimeters to about 12 millimeters, from about 5 millimeters toabout 10 millimeters, from about 6 millimeters to about 8 millimeters,or other lengths or ranges of lengths.

The collar 18 includes a lumen or opening 657 extending axiallytherethrough. The opening 657 allows for receiving portions of the frame10, such as the struts 12, proximal apex 14, and the threaded shaft 646,therein. There may be a single opening 657 extending through the collar18 that surrounds all of the features therein. In some embodiments, theopening 657 may include one or more axial side channels, which may ormay not be structurally separated from the opening 657, as furtherdescribed. The opening 657 may extend from a proximal end to a distalend of the collar 18. The opening 657 may have a generally rectangularcross-section. In some embodiments, the opening 657 may have othercross-section shapes, such as a circular, rounded, partially rounded, orcontoured shape to match complementary surface contours of the threadedshaft 646 and/or frame 10 such as the struts 12. The opening 657 mayhave a cross-sectional profile, for example perpendicular to thedirection of axial extension of the body and opening 657 of the collar18, that has a centrally wider portion compared to side portions, forrespectively receiving and fitting around the shaft 646 and struts 12.The central portion may be rounded and the side portions may be squareor rectangular, as generally shown in FIG. 39. The central portion maybe part of the opening 657 and the side portions may be part of firstand second axial channels 654, 656, as further described.

The collar 18 includes one or more inner surfaces 652. The innersurfaces 652 may extend along an inner side or sides of sidewalls of thecollar 18 from a proximal end to a distal end thereof. The innersurfaces 652 may form inner boundaries of the opening or openings 657.The inner surface or surfaces 652 of the collar 18 are provided with acomplementary engagement surface structure 653 for engaging the threadedshaft 646, such that rotation of the threaded shaft 646 interacts withthe complementary surface structure 653 and causes the collar 18 totranslate in a proximal or distal direction relative to the threadedshaft 646. Rotation of the threaded shaft 646 in a first rotationaldirection, such as clockwise, will cause movement of the collar 18 in afirst translational direction, such as a distal direction. Rotation ofthe threaded shaft 646 in a second rotational direction opposite thefirst rotational direction, such as counter-clockwise, will causemovement of the collar 18 in a second translational direction oppositethe first translational direction, such as a proximal direction.

The collar 18 may change the angles of adjacent struts 12 (the “angle C”between adjacent struts 12, as shown for example in FIG. 44C) by movingover the struts 12 to close or decrease the angle C between adjacentstruts 12, or to open or increase the angle C, as described. The collar18 may lock the struts 12 at a given angle due to moving over the struts12. In some embodiments, the collar 18 may cause, for example push, asecondary slider located distally to the collar 18 to move over thestruts 12 to decrease the angle C. A secondary slider may be used thatalso locks the angle of the struts 12 in place to account for anypossible backing off of the collar 18, for example undesirable distalmovement of the collar 18, after implantation.

The complementary surface structure 653 may be a complementary helicalthread to slidably and/or rotatably engage some or all of the outerthreads 674 of the threaded shaft 646. A mating internal thread patternon the collar 18 (e.g. cut thread, rolled thread or alternative method)may mate with the threaded shaft 646. The collar 18 may translate, i.e.move linearly, due to a rotation of the threaded shaft 646, asdescribed.

In some embodiments, features of a rack and pinion gear system may beincorporated. In some embodiments, the complementary surface structure653 may be one or more tabs or teeth extending radially inwardly fromthe inner surface 652. The complementary surface structure 653, such astabs or teeth, may be arranged in a ladder-like configuration along allor a portion of one or more of the inner surfaces 652.

The complementary surface structure 653 may extend in a proximal and/ordistal direction. For example, radially inner and outer sides of theinner surface 652, as assembled with the frame 10, may include thecomplementary surface structure 653, such as portions of a threadedsurface drilled into and through the collar 18, or a series of tabs,teeth, etc. in a ladder-like configuration, etc. The inner threads, tabsor other features of the complementary surface structure 653 may belocated within the collar 18 and extend along the proximal and/or distaldirections. The complementary surface structure 653 may extend alongthis length, or it may be broken into separate sub-structures that arelocated along this length. The complementary surface structure 653 mayextend entirely or partially along the axial length of the inner surface652. The complementary surface structure 653 may be located centrallyrelative to the opening 657. Further details of the internal engagementfeatures of the collar 18 are described herein, for example with respectto FIGS. 45A-45B.

In some embodiments, various locking features may be incorporated intothe threads 647 of the threaded shaft 646 and/or into the complementarysurface structure 653. For example, features related to self-lockingfasteners or nuts, modified male or female threads, etc. may beincorporated to produce a self-locking engagement that is resistant toloosening due to cyclic loading, vibrations and other environmentaldisturbances.

The lumen or opening 657 of the collar 18 may include one or moreaxially extending channels. The collar 18 may include a first channel654. The first channel 654 may be a portion of the opening 657, such asa side portion thereof. The first channel 654 may slidably receive thefirst strut 12A. The collar 18 may include a second channel 656. Thesecond channel 656 may be a portion of the opening 657, such as a sideportion thereof that is opposite the first channel 656. The secondchannel 656 may slidably receive the second strut 12B. The opening 657may form a central portion that surrounds the shaft 646. In someembodiments, the first and/or second channels 654, 656 may bestructurally separated from the opening 657. For example, the firstand/or second channels 654, 656 may be separated, entirely or partially,by a wall or other divider that separates and prevents contact betweenthe struts 12A, 12B and the threaded shaft 646.

Each of the first and second channels 654, 656 may comprise at least onefirst surface 658. The first surface 658 may engage, for exampleslidably engage, the respective strut 12A, 12B. Engagement of the firstsurface 658 with the struts 12A, 12B may prevent and/or limit rotationof the collar 18 about its axis. As the threaded shaft 646 is rotated,rotational forces may be imparted to the collar 18. The collar 18 maythus rotate until the one or more first surfaces 658 contacts the strut12A. The first surface 658 may be a region of the inner surface 652. Insome embodiments, the first surface 658 may be a part coupled with orbuilt integrally into the inner surface 652. There may be multiple firstsurfaces 658, for example corresponding to opposite sides ofcorresponding struts 12A, 12B. For clarity, only one of the firstsurfaces 658 is labelled in FIG. 39. There may be four first surfaces658, with two first surfaces 658 on radially inward and radially outwardsides of the strut 12A, and two first surfaces 658 on radially inwardand radially outward sides of the strut 12B. One, some or all of thefirst surfaces 658 may contact corresponding side surfaces of therespective struts 12A, 12B to prevent or limit rotation of the collar18. In some embodiments, rotation of the collar 18 in a first rotationaldirection will cause diagonally opposite first surfaces 658 to contactthe struts 12A, 12B, and rotation of the collar 18 in a second oppositerotational direction will cause the other of diagonally opposite firstsurfaces 658 to contact the struts 12A, 12B.

As further shown in FIG. 39, in some embodiments, the implant 1 mayinclude an end cap 659. The end cap 659 may be a structural membercoupled with the apex 14, such as with the medial flanges 636 and/or638. The end cap 659 can be placed on the struts 12 that make up thewindow 634 to capture, or otherwise prevent dislodgment of, the theadedshaft 646. The end cap 659 may extend from a proximal end of the firstand second supports 630, 632 in a generally radially inward or outwarddirection, i.e. toward or away from the central longitudinal axis of theframe 10. The end cap 659 may be integral with the frame 10 or may be aseparate part attached thereto. The end cap 659 may thus facilitateretention, for example radial retention, of the threaded shaft 646. Forexample, after driving the collar 18 distally to angle the struts 12A,12B, the end cap 659 may provide a retaining feature to assist withradially retaining the proximal end of the threaded shaft 646.

The positioning of the collar 18 over the threaded shaft 646 may alsoprevent the threaded shaft 646 from falling out of the window 634 in theframe 10 and dislodging from the implant 1. In some embodiments, thewindow 634 may have an open proximal side as shown. As described above,in some embodiments, the window 634 may be an enclosed region. Forexample, the open proximal side may be closed, such as with a bridge orwith connected flanges 636, 638, but have an axial opening such as ahole therethrough, with the threaded shaft 646 and/or other featuresextending therethrough into the window 634 and engaging with the collar18.

FIGS. 40A and 40B depict embodiments of coupling features that may beused with the implant 1 and a delivery system to rotate the threadedshafts 646. FIG. 40A is a partial perspective view of an embodiment ofthe implant 1. The implant 1 is shown as having an axially translatablecollar 18 and a rotatable threaded shaft 646 nested within the frame 10and located internally to the collar 18. The implant 1 includes acoupling 660 for engagement by a driver coupling 666 for rotating thethreaded shaft 646 to cause axial movement of the collar 18. FIG. 40B isa partial perspective view of an embodiment of the driver coupling 666that may be used with the implant coupling 660.

The threaded shaft 646 may be driven with one or more coupling features.Any of a variety of complementary couplings may be utilized, between thethreaded shaft 646 and the driver coupling 666. As shown in FIG. 40A,the proximal end of the threaded shaft 646 may be provided with thecoupling 660. The coupling 660 may allow for releasable engagement ofthe coupling 660 with the driver coupling 666. The proximal end of thethreaded shaft 646 may be provided with the coupling 660, eitherdirectly or indirectly coupled thereto. The coupling 660 may couple withthe proximal member 655, such as a post, as described with respect toFIG. 38B. In some embodiments, there is no proximal member 655 such as apost and there is only the coupling 660. The coupling 660 may beintegral with the proximal end of the threaded shaft 646. The coupling660 may be a separate part that is attached, for example welded, bonded,fastened, etc. to the threaded shaft 646. The coupling may be made ofthe same or similar materials as the threaded shaft 646, or othersuitable materials.

Referring to FIG. 40A, an example axis of rotation of the coupling 660on the right, as oriented in the figure, is shown. The correspondingdistal axial movement of the corresponding collar 18 is indicated by thedistal pointing arrow next to the collar 18. The axis of rotation 660 ofthe coupling 660 may align with the axis of rotation of the threadedshaft 646, as shown. In some embodiments, the axis of rotation of thecoupling 660 may be parallel but not coincident with the axis ofrotation of the threaded shaft 646. In some embodiments, the axis ofrotation of the coupling 660 may not be parallel with the axis ofrotation of the threaded shaft 646. For example, the coupling 660 may becoupled with the threaded shaft 646 using an angled or rotatable fittingwhereby rotation of the coupling 660 about a first axis transmitsrotation to the threaded shaft 646 about a second axis that is angledrelative to the first axis.

The coupling 660 may comprise a lateral projection 662. The lateralprojection 662 may extend perpendicularly or generally perpendicularlyto the axis of rotation of the coupling 660. The lateral projection 662may extend in a variety of directions, including at angles other thanninety degrees relative to the axis of rotation. In some rotationalorientations of the coupling 660, the lateral projection 662 may extendtangentially or generally tangentially to a circumferential directionrelative to the rounded frame 10 of the implant 1. However, the coupling660 may be rotated such that the lateral projection may extend in avariety of directions relative to the frame 10.

The lateral projection 662 may extend over a base 661 of the coupling660. The lateral projection 662 may extend for a portion of the width ofthe base 661. The base 661 may be coupled with (i.e. attached directlyor indirectly with) the threaded shaft 646 in any of the mannersdescribed above. In some embodiments, the lateral projection 662 mayextend for a quarter of, half of, three quarters of, the entire, or morethan the entire width of the base 661, or other amounts.

The lateral projection 662 may overhang a recess surface 664. The recesssurface 664 may be located distally to the lateral projection 662. Therecess surface 664 may be an inner surface or surfaces of the coupling660 extending at or near a proximal region of the base 661 and to ornear a distal region of the lateral projection 662, and anywhere inbetween. The recess surface 664 may follow a generally rounded contouras shown. In some embodiments, the recess surface 664 may be straight,rounded, segmented, polygonal, other suitable shapes or contours, orcombinations thereof.

The lateral projection 662 and recess surface 664 may form or define alaterally opening recess 665. The laterally opening recess 665 maydefine an opening or window configured to be coupled with acorresponding driver or delivery system feature for engagement of thecoupling 660, as further described. The laterally opening recess 665 mayopen perpendicularly or generally perpendicularly to the axis ofrotation of the threaded shaft 646. In some embodiments, the laterallyopening recess 665 may open at angles other than ninety degrees or aboutninety degrees relative to the axis of rotation. In some embodiments,the coupling 660 may be rotated such that the laterally opening recess665 faces a different direction. For example, in FIG. 40A as oriented,the couplings 660 on the left and right are rotated and thecorresponding laterally opening recesses 665 each faces in a differentlateral direction. Therefore “lateral” is not restricted tocircumferential, but may be any direction that is generallyperpendicular (or at other angles) to the axis of rotation of thecoupling 18. For instance, the coupling 660 on the right as oriented isshown rotating about the rotation axis as indicated. The laterallyopening recess 665 may face in any direction that is generallyperpendicular to this axis. In some embodiments, the laterally openingrecess 665 may be angled with respect to such perpendicular direction.For example, the laterally opening recess 665 may open in a proximal ordistal direction at an angle relative to such perpendicular direction.

Also shown in FIG. 40A is one of the proximal apexes 14 (on the left asoriented in the figure) without the collar 18 to show various possiblefeatures of the threaded shaft 646. For example, the threaded shaft 646may have a proximal connector 663 and a distal connector 667, as shownin FIG. 40A. The proximal connector 663 may extend proximally from aproximal end of the threaded portion of the threaded shaft 646. Theproximal connector 663 may connect the threaded portion of the threadedshaft 646 with the coupling 660. The proximal connector 663 may beintegral with the threaded portion and/or the coupling 660. The distalconnector 667 may extend distally from a distal end of the threadedportion of the threaded shaft 646. The distal connector 667 may connectto a base 669 of the threaded shaft 646. The distal connector 667 may beintegral with the threaded portion and/or the base 669. Thus, in someembodiments, the coupling 660, the proximal connector 663, the threadedportion of the threaded shaft 646, the distal connector 667 and the base669 may be an integral, monolithic piece. The various parts or portionsof the threaded shaft 646 may complement openings or other features ofthe frame 10, as further described herein, for example with respect toFIG. 41.

Referring to FIG. 40B, a portion of an embodiment of a driver system 680for use with the various implants described herein, such as the implant1, is shown. The driver system 680 may be used with the various driverand delivery systems described herein, for example the driver tube 260and delivery catheter 40 as shown, and described above. For clarity onlya portion of the delivery catheter 40 and one driver tube 260 are shown.There may be additional driver tubes 260 extending from the distal endof the delivery catheter 40, as described above. In addition oralternatively, in some embodiments, the driver system 680 may be usedwith other delivery and driver features and/or implants describedherein, such as the driver tubes 22′, the delivery catheter 240, thedelivery system 400, the steerable sheath 402, the steerable catheter602, the implants 1A, 1B, 1C, 100, 101, 102, 103, 104, 105, 500, 520,520′, 530, etc.

The driver system 680 may include a driver coupling 666. The drivercoupling 666 may releasably engage with and drive, for example rotate,the coupling 660 of the implant 1. A surface structure or structures ofthe driver coupling 666 complementary to a surface or surfaces of theimplant coupling 660 may be provided on a distal end of the driversystem 680. As shown, the driver coupling 660 may include a lateralprojection 668, a recess surface 670, a base 671, and an opening recess672, which may have the same or similar features and/or functionalitiesas, respectively, the lateral projection 662, the recess surface 664,the base 661, and the opening recess 665 of the implant coupling 660.The driver coupling 666 may thus complement the implant coupling 660 toallow for engagement of the couplings 660, 666.

The driver coupling 666 may be engaged with the implant coupling 660 byextending the driver coupling 666 to a position adjacent the implantcoupling 660. The lateral projection 668 of the driver coupling 666 maythen be inserted into the opening recess 665 of the implant coupling660, and the lateral projection 662 of the implant coupling 660 may beinserted into the opening recess 672 of the driver coupling 666. The twolateral projections 662, 668 may be inserted to respective openingrecesses 672, 665 simultaneously. The various complementary surfaces ofthe two couplings 660, 660 may contact or otherwise engage with eachother, either completely or partially, for example the recess surfaces664 and 670, etc.

When engaged, the couplings 660, 666 may be restrained from translatingin one or more directions but free to translate in one or more otherdirections. For example, the couplings 660, 666 when engaged may be freeto move in a first direction that is perpendicular to directions ofextension of the lateral projections 662, 668, but the couplings 660,666 may be restrained from movement in the remaining two directions thatare perpendicular to this first direction. Thus, the engagement mayrestrain movement in two dimensions but allow for movement in onedimension, with respect to a three-dimensional or three-axis system.Similarly, the couplings 660, 666 when engaged may be free to rotateabout the rotation axis but restrained from rotation about axesperpendicular to the rotation axis. Rotation of the driver coupling 666transmits forces to the implant coupling 660, for example to the recesssurface 664, to cause rotation of the implant coupling 660. Thus, thedriver coupling 666 and the implant coupling 600 may rotate together asa unit, with the driver coupling 666 controlling the rotation and theimplant coupling 660 passively rotating in response to the forcesimparted from the rotating driver coupling 666.

The driver coupling 666 may be held in engagement with the coupling 660on the threaded shaft 646 by an outer tubular sleeve 674. The sleeve 674may be axially retractable to expose the driver coupling 666. Afterengagement of the coupling 660 with the driver coupling 666, the sleeve674 may then be axially advanced in a distal direction to cover theengaged couplings 660, 666. The sleeve 674 may completely or partiallysurround the couplings 660, 666. The sleeve 674 may ensure the couplings660, 666 remain engaged, for example by preventing uncoupling in adirection that is perpendicular to the direction of extension of thelateral projections 6682, 668. The sleeve 674 may be rounded as shown,or have other shapes. In some embodiments, the sleeve 674 may comprisetwo prongs extending in a distal direction that cover sides of thelateral projections 662, 668 to prevent de-coupling of the lateralprojections 662, 668 in directions perpendicular to the direction ofextension of the lateral projections 6682, 668.

The driver coupling 666 may be coupled with a distal end of the drivertube 260. Actuation, for example rotation, of the driver tube 260 maytransmit rotation to the driver coupling 666. The driver coupling 666may engage with and rotate the coupling 660, as described, with thesleeve 674 extended distally about the engaged couplings 660, 666. Insome embodiments, the driver coupling 666 may be driven in the reverserotational direction to cause proximal axial advancement of the collar18, for example to allow for or cause an increase in the angle betweenadjacent struts 12. The driver coupling 666 may be driven in the reverserotational direction with the sleeve 674 extended distally about theengaged couplings 660, 666.

After the desired distal or proximal advancement of the collar 18, thesleeve 674 may be retracted proximally to expose the engaged couplings660, 666. Proximal retraction of the sleeve 674 exposes the interlockedcouplings 660, 666 thus allowing the driver coupling 666 to be releasedfrom the implant coupling 660. The driver coupling 666 may thus bedisengaged or released from the implant coupling 660. For example, thedriver coupling 666 may be moved perpendicular to the direction ofextension of the lateral projection 668 to disengage the respectivelateral projections 662, 668. The driver coupling 666 may then beretracted from the heart by the delivery system 680 and removed from thebody. Similar engagement, covering, driving, uncovering, disengagementand removal methods and techniques may be performed for each coupling660 of the implant 1. A separate driver coupling 666 and correspondingdriver tube 260 may be used for rotating each implant coupling 660.

A variety of advantages result from the features described herein. Forexample, by having the threaded shaft 646 located internally to thecollar 18, a smaller torque or rotational force is required to beexerted to move the collar 18. Because the moment arm for the threadedshaft 646 located internally to the collar 18 is much smaller relativeto the moment arm of an externally located member that would surroundthe collar 18, such as a socket, the torque required to be transmittedby the surgeon is much smaller. The rotational force or torque (T)applied to an object or required to be overcome is equal to the momentarm or distance (D) from the rotational center times the force (F)applied at that distance, or T=F×D. Thus, the rotation of an internalmember, i.e. a member located internally of the collar 18, requires asmall torque T due to the small distance from the location of the centerof rotation, i.e. a small “D”. The resulting torque that must beovercome to turn the shaft is thus much smaller. This enhancesreliability and ease of use of the driver system 680, as the torque in atranscatheter delivery system must be transmitted along the entirelength of the driver through the catheter 40. By requiring a smallertorque to be transmitted, the implant 1 is more easily and simplycinched. Further, this eases requirements of other parts of the system.For example, the material and geometry of the length of the driver tube260 that must transmit the torque over the long distance through thecatheter 40 lumen need not sustain large torques, simplifying design andconstruction, and enhancing the reliability and robustness of the driversystem 680.

FIG. 41 is a partial perspective view of an embodiment of the implant 1having a contoured collar 18 and with various features at or near theproximal apex 14 removed for clarity. The implant 1 has an axiallytranslatable collar 18 that is contoured. The collar 18 has contouredsidewalls to match the contours of the struts 12 and the threaded shaft646. Thus a central bulge protrudes along radially inward and outwardsides of the collar 18. The collar 18 may be contoured for a reducedcrossing profile design, which may for example prevent excess rotationof the collar 18 before engaging with the struts 12 to prevent furtherrotation of the collar 18, provide a smaller delivery configuration ofthe implant 1, etc.

As shown in FIG. 41, on one of the apexes 14 (to the left of the figureas oriented), the collar 18, threaded shaft 646 and coupling 660 havebeen removed for purposes of illustration. The exposed proximal apex 14is at the proximal end of the struts 12C, 12D. First and second supports630, 632 extend proximally therefrom and terminate at medial flanges636, 638, as described herein. Additionally, the medial flanges 636, 628have openings 637, 633 respectively. The openings 637, 633, for exampleholes, extend through the flanges 636, 628. The openings 637, 633 may beused to attach various features to the frame 10, such as the end caps659 as described herein.

The frame 10 includes the window 634, as described. Additionally, theframe 10 may include a lower window 639 as shown. The lower window 639is separated from the window 634 by first and second projections 641,643. The first projection 641 extends from the first support 630 towardthe second support 632, and the second projection 643 extends from thesecond support 632 toward the first support 630, at a distal end of thewindow 634. A gap 645 is formed in between the two projections 641, 643.The gap 645 separates the window 634 from the lower window 639. Further,the frame 10 may include the central aperture 640, as described, forexample in between the medial flanges 636, 638.

The threaded shaft 646 may have complementary features for insertioninto the central aperture 640, window 634, gap 645, and/or lower window639. The threaded shaft 646 may have the coupling 660, proximalconnector 663, the distal connector 667, and/or the base 669, asdescribed with respect to FIG. 40A. When the threaded shaft 646 isassembled with the frame 10, the coupling 660 may be proximal to themedial flanges 636, 638, the proximal connector 663 may be locatedwithin the central aperture 640, the threaded portion of the threadedshaft 646 may be located within the window 634, the distal connector 667may be located within the gap 645, and/or the base 669 may be locatedwithin the lower window 639. The threaded shaft 646 may thus be retainedat or near the apex 14 of the frame 10 by the corresponding structuralfeatures of the frame 10. In addition or alternatively, other suitablefeatures may be used to retain the threaded shaft 646 with the frame 10,as further described.

FIG. 42 is a flattened perspective view of another embodiment of theimplant 1 with a frame 10 having a proximal post 690 and a roundedcollar 18. The implant 1 has the axially translatable collar 18 and therotatable threaded shaft 646 surrounding the proximal post 690 of theframe 10 and located internally to the collar 18. The collar 18 has agenerally cylindrical shape. The collar 18 may have an internalengagement structure such as internal threads, as described, thatengages with the external engagement feature, such as external threads,of the threaded shaft 646 to axially translate the collar 18.

The post 690 may extend proximally from the proximal apex 14. As anexample, the proximal apex 14 may be at the proximal end of the struts12E, 12F, with the proximal post 690 extending therefrom. Each proximalapex 14 may have the proximal post 690. The threaded cannulated shaft646 may extend over the proximal post 690, such that the proximal post690 extends through or into an opening or recess of the threaded shaft646. In some embodiments, the driver system 680 may utilize the proximalpost 690 where the threaded shaft 646 is allowed to rotate on or overthe proximal post 690 while trapped or pinned onto the proximal post 690thereby preventing or substantially preventing axial movement of thethreaded shaft 646. The threaded shaft 646 may bottom out at theproximal apex 14. In some embodiments, an internal proximal end of acentral opening through the threaded shaft 646 may bottom out on theproximal end of the proximal post 690. The proximal post 690 may have acylindrical shape to accommodate a rotating shaft 646. In someembodiments, there may be a bushing in between the post 690 and theshaft 646 to facilitate rotation of the shaft 646.

FIG. 43 is a flattened perspective view of another embodiment of theimplant 1. As shown the implant 1 may include the frame 10 having theproximal post 690 and a proximal stop 692. As further shown, the implant1 may have a rounded collar 18 having an expanded distal portion 21. Theproximal stop 692 may mechanically communicate with the threaded shaft646. The proximal stop 692 may provide features for engagingcomplementary features of the threaded shaft 646. In some embodiments,the proximal stop 692 may be an elongated member, such as a cylinder orother shape, extending through the proximal post 690 from one side toanother thereof. In some embodiments, the proximal stop 692 may protrudeoutward from one or more side surfaces of the proximal post 690. Forexample the proximal stop 692 may extend outward from two opposite sidesof the proximal post 690 and be received into an annular groove on aninternal surface of the threaded shaft 646 to prevent axial movement ofthe threaded shaft 646 relative to the proximal stop 692 while allowingfor rotation of the threaded shaft 646 about the proximal post 690. Insome embodiments, the proximal stop 692 may be a recess or hole in thepost 690. Such stop 692 may receive a complementary inward protrusionfrom the shaft 646 or coupling 660, for example to limit or preventrotation.

The threaded shaft 646 may have a complementary opening in a sidewall ora recess along an inner wall thereof near a proximal end of the threadedshaft 646. For example, the threaded shaft 646 may be a hollow cylinderwith an inner wall having a radial opening therethrough or an annularrecess along an inner surface thereof at a proximal end. The threadedshaft 646 may be slid over the proximal post 690 such that the proximalpin 692 extends into the complementary features within the threadedshaft 646, such as through the opening or within the annular recess. Theengagement of the proximal pin 692 with the threaded shaft 646 mayrestrain movement of the threaded shaft 646 in the axial directionsproximally and distally while allowing for rotation of the threadedshaft 646 about the proximal post 690. In some embodiments, the proximalpin 692 may be retractable such that the threaded shaft 646 may be slidover the pin 692 until the complementary features within the threadedshaft 646 allow the pin 692 to pop back out and engage the threadedshaft 646. In some embodiments, there may be a friction fit between theproximal pin 692 and the threaded shaft 646. The rotation of thethreaded shaft 646 may drive the collar 18 over the struts 12 changingthe angle C (see FIG. 44C) between the adjacent struts 12 as the collar18 travels up and down the frame 10. Thus, the threaded shaft 646 mayrotate about the proximal post 690. In some embodiments, the collar 18may be rotated over the threaded shaft 646. For example, the threadedshaft 646 may be rotationally stationary and the collar 18 may berotated over the threaded shaft to translate the collar 18 axially.

The collar 18 may include the expanded distal portion 21 having anexpanded width, e.g. diameter, relative to other portions of the collar18. As shown, the expanded distal portion 21 may be circular and have acutout at a proximal end thereof.

Further shown in FIG. 43 is an embodiment of the coupling 660 having acap 673. The cap 673 may be a rounded, for example cylindrical, memberwith a distal opening configured to receive therein a proximal portionof the threaded shaft 646. The cap 673 may include a side window 675.The side window 675 may be an opening in the sidewall of the cap 673. Insome embodiments, the proximal pin 692 may extend into the side window675 to engage the cap 673. Rotation of the cap 675 via the coupling 673will cause the proximal pin 692 to contact portions of the cap 675adjacent the side window 675, thus transmitting rotation of the coupling660 to the threaded shaft 646.

FIGS. 44A-44C depicts various views of an embodiment of the implant 1having flared proximal ends 2, for example after anchoring the implant 1to heart tissue. FIG. 44A is a perspective view, FIG. 44B is a top(proximal end) view, and FIG. 44C is a side view. The features andfunctionalities of the implant 1 shown in and described with respect toFIGS. 44A-44C may apply to any other implants described herein, forexample the implants 1A, 1B, 1C, 100, 101, 102, 103, 104, 105, 500, 520,520′, 530, including embodiments of the implant 1 shown in and describedwith respect to FIGS. 38A-43, and vice versa.

As shown in FIGS. 44A-44C, the implant 1 is shown having the frame 10with the proximal end 2 and the distal end 4. A series of struts areconnected to form a series of the proximal apexes 14 and a series of thedistal apexes 16. The proximal apexes each have an embodiment of thecollar 18, here shown as a slidable collar 18. It is understood that anyof the collars described herein may be incorporated, including but notlimited to the collar 18 shown in and described with respect to FIGS.38A-43 that is driven axially by the internally rotating threaded shaft646, as described. For clarity, only some of the features in FIGS.44A-44C are labelled.

As shown, the implant has a “flared” proximal end 2. The proximal end 2of the implant 1, for example the portion of the implant 1 above thedistal apexes 16, inclines radially outward in the proximal directionrelative to a central longitudinal axis of the implant 1 to give it theflared shape. The struts 12 may extend proximally and radially outwardto form a generally frustoconical shape. In some embodiments, theimplant 1 may not be circular and so the flared shape may not be exactlyfrustoconical. The implant 1 may have the flared shape before, during,and/or after anchoring the implant 1 to the heart tissue. As shown, theanchors 20 are extended distally and may be anchored into heart tissue(not shown). In some embodiments, the implant 1 may not be flared beforeanchoring and may take the flared shape after engaging the helicalanchors 20 with tissue. The engagement of the anchors 20 may cause theimplant 1 to have the proximally flared shape. In some embodiments, theimplant 1 may assume the flared shape after removal of the driversconnected to the rotatable shafts 646. For example, each proximal apex14 may flare outward upon removal of a corresponding driver oradjustment catheter from the corresponding shaft 646 or coupling forthat particular apex 14.

The proximal end 2 of the implant 1 may be inclined varying amounts. Asshown, the struts 12 may be inclined radially outward relative to thecentral longitudinal axis of the implant 1 by an angle A. The angle Amay be from about five degrees to about seventy-five degrees, from aboutfive to about sixty degrees, from about ten degrees to about seventydegrees, from about fifteen degrees to about sixty-five degrees, fromabout fifteen to about thirty degrees, from about twenty degrees toabout sixty degrees, from about twenty-five degrees to about fiftydegrees, from about thirty degrees to about forty-five degrees, or anyother amounts or ranges. In some embodiments, the angle A may be zero ornear zero such that the proximal apex 14 does not incline or onlyinclines slightly radially outward. In some embodiments, the angle A maybe negative such that the proximal apex 14 inclines radially inward.

The angle A may change based on the stage of delivery and anchoring. Insome embodiments, the angle A may change based on the number and/oramount of advancement of each of the collars 18 distally alongcorresponding pairs of struts 12. For example, the angle A may change agiven angular amount based on amount of displacement or advancement ofthe collar 18 and/or rotational movement of the threaded shaft 646. Insome embodiments, the angle A may increase or decrease by at least about5 degrees or 15 degrees or 25 degrees or more degrees given axialadvancement of the collar 18 by about 1 or 2 or 3 or more millimeters.In some embodiments of the implant 1 with the rotatable threaded shaft646, two turns of the threaded shaft 646 produces about 5 millimeters ofoutward anchor 20 displacement. In some embodiments of the implant 1with the slidable collar 18, a two millimeter advancement of theslidable collar 18 provides an outward anchor 20 movement of about 7.5millimeters at the anchors 20.

In some embodiments, the angle A may increase by a factor of at leastabout 5× relative to the movement of the collar 18. For instance, eachone millimeter of travel of the collar 18 may result in at least aboutthree degrees or at least about five degrees radially outward swing or“flare” of the corresponding proximal apex 14. In some embodiments, theangle A may change based on other factors, such as the number and/oramount of insertion of each of the anchors 20 into tissue. Further, theangle A may not be uniform for all of the proximal apexes 14. Forinstance, a first proximal apex 14 may be inclined radially outward at afirst angle, and a second proximal apex 14 may be inclined radiallyoutward at a second angle, where the first angle is greater than thesecond angle. Therefore, none, some or all of the proximal apexes 14 maybe inclined at the same angle A.

In some embodiments, the distal end 4 of the implant 1 may also beflared outward. For example, the anchors 20 may incline radially outwardin the distal direction as shown, which may be before, during, and/orafter engagement of the anchors 20 with tissue. The distal end 4 of theimplant 1 may be inclined varying amounts. As shown, the anchors 20and/or distal apexes 16 may be inclined radially outward relative to thecentral longitudinal axis of the implant 1 by an angle B. The angle Bmay be from about five degrees to about seventy-five degrees, from aboutfive to about sixty degrees, from about ten degrees to about seventydegrees, from about fifteen degrees to about sixty-five degrees, fromabout fifteen to about thirty degrees, from about twenty degrees toabout sixty degrees, from about twenty-five degrees to about fiftydegrees, from about thirty degrees to about forty-five degrees, or anyother amounts or ranges. In some embodiments, the angle B may be zero ornear zero such that the distal apex 16 does not incline or only inclinesslightly radially outward. In some embodiments, the angle B may benegative such that the distal apex 16 inclines radially inward.

The angle B may change based on the stage of delivery and anchoring, forexample as described with respect to the angle A above. Further, theangle B may not be uniform for all of the anchors 20 or distal apexes16. For instance, a first anchor 20 may be inclined radially outward ata first angle, and a second anchor 20 may be inclined radially outwardat a second angle, where the first angle is greater than the secondangle. Therefore, none, some or all of the anchors 20 or distal apexes16 may be inclined at the same angle B.

Further, the angles A and/or B may change based on the amount ofinsertion of the anchors 20 and/or the number of anchors 20 insertedinto tissue. In some embodiments, the angles A and/or B may change byone, two, three, four, five, or more degrees for each millimeter ofadvancement of either the anchors 20 or the collars 18. In someembodiments, the angles A and/or B may change by two, five, ten,fifteen, or twenty percent for each millimeter of advancement of eitherthe anchors 20 or the collars 18. The distances and percentages maychange, for example be greater or smaller, based on the particulargeometry of the implant 1 and the frame 10, as well as particularanatomical features of the patient.

The flared shapes of the various portions of the implant 1 may enhancesecurement and functioning of the implant 1. For example, the flareddistal end 4 may provide a more secure engagement as removal of theanchors 20 requires movement of the anchors 20 along non-parallel lines,thus reducing the chances that forces acting on the implant 1 will causeit to dislodge. As further example, the flared proximal end 2 mayprovide a greater opening to facilitate blood flow through the implant 1and heart valve annulus. The flared configurations shown are merelyexamples and other variations of the flared aspects may be implemented.

FIGS. 45A and 45B are cross-sections views of embodiments of the collar18 having various complementary surface structures 653. As shown, thecollar 18 has a body 800 that includes sidewalls 802, 804, 806. Theradially inward sidewall 802 may be located on a radially-inward side ofthe collar 18 as oriented when assembled with the implant 1. Thus“radially inward” here refers to a side relatively nearer the centrallongitudinal axis of the implant 1. A radially outward sidewall (notshown) may be located opposite the radially inward sidewall 802.“Radially inward” here refers to a side relatively farther from thecentral longitudinal axis of the implant 1. Sidewalls 804 and 806 mayconnect the radially inward sidewall 802 to the radially outwardsidewall. The body 800, for example the sidewalls, may extend from aproximal end 808 to a distal end 810 of the collar 18.

The cross-section views of the collar 18 show a portion of the innersurface 652. The inner surface 652 extends from the proximal end 808 tothe distal end 810 along interior sides of the sidewalls. The opening657 is also shown extending from the proximal end 808 to the distal end810. The channels 654, 656, which are shown as part of the opening 675but which may be separated as described, extend from the proximal end808 to the distal end 810 along the radially inward sidewall 802. Thechannels 654, 656 may also extend extend from the proximal end 808 tothe distal end 810 along the radially outward sidewall. The firstsurfaces 658, as described, are shown extending from the proximal end808 to the distal end 810 along the radially inward sidewall 802. Thefirst surfaces 658, may also extend from the proximal end 808 to thedistal end 810 along the radially outward sidewall.

Further shown in FIGS. 45A and 54B are embodiments of the complementarysurface structures 653. FIG. 45A shows an embodiment of thecomplementary surface structure 653 including internal threads 811. Forclarity, only some of the threads 811 are labelled in the figure. Thethreads 811 may extend axially from the proximal end 808 to the distalend 810 along the inner surface 652, or along any portion or portionstherebetween. The threads 811 are incomplete, meaning less than a fullrevolution of the threads 811 are present. In some embodiments, thethreads 811 may be complete, for example where a divider separates theopening 657 form the channels 654, 656, as described. The threads 811are located on the radially inward sidewall 802. The threads 811 mayalso be located on the readily outward sidewall (not shown). In additionor alternatively, in some embodiments, the threads 811 may be locatedalong inner surfaces 652 of the sidewalls 804, 806. The threads 811 mayinterrupt or separate the first surfaces 658 as shown.

FIG. 45B shows an embodiment of the complementary surface structure 653including a series of teeth 812. For clarity, only some of the teeth 812are labelled in the figure. The teeth 812 may extend axially from theproximal end 808 to the distal end 810 along the inner surface 652, oralong any portion or portions therebetween. Each of the teeth 812 asshown may extend perpendicularly to a longitudinal axis of the collar18, or the teeth 812 may be angled relative to the axis. Each of theteeth 812 may extend along a sidewall for a portion thereof in a lateraldirection. The teeth 812 are located on the radially inward sidewall802. The teeth 812 may also be located on the readily outward sidewall(not shown). In addition or alternatively, in some embodiments, theteeth 812 may be located along inner surfaces 652 of the sidewalls 804,806. The teeth 812 may interrupt or separate the first surfaces 658 asshown.

FIG. 46 is a flowchart showing an embodiment of a method 900 forreshaping a mitral valve annulus. The method 900 may be performed with avariety of the implants described herein, including but not limited tothe various embodiments of the implant 1 described with respect to FIGS.38A-45B.

The method 900 begins with step 910 wherein an implant is positionedadjacent a mitral valve annulus. The implant may be the implant 1, andit may be positioned using the transcatheter delivery systems describedherein or other delivery systems, including but not limited to thedelivery system 400. The implant may have a tubular frame having a pairof struts, a rotatable shaft carried by the frame, a translatable collarengaged with the rotatable shaft and at least partially surrounding thepair of struts, and an anchor coupled with the frame. In someembodiments, the implant 1 includes the frame 10, struts 12, shaft 646,collar 18 and anchors 20, including but not limited to those describedwith respect to FIGS. 38A-44B.

The method 900 next moves to step 920 wherein the anchor is secured totissue of the mitral valve annulus. In step 920, the anchor may be theanchor 20, or other anchors. Thus, step 920 may include rotating ahelical anchor through a distal end of the frame to rotatably engage thetissue. In step 920, the anchors may be secured at an angle with respectto a central longitudinal axis of the implant, for example flared orinclined radially outward in a distal direction.

The method 900 next moves to step 930 wherein the shaft is rotated tocause the collar to translate along the first pair of struts. Step 930may include rotating the threaded shaft 646 to cause the collar 18 totranslate along the struts 12 in a distal direction. In step 930, theshaft may be rotated using the various drivers described herein,including but not limited to the delivery system 680 and the drivercoupling 666, etc.

The method 900 next moves to step 940 wherein an angle between the firstpair of struts is decreased due to translation of the collar. Step 940may include decreasing the angle between the struts 12A, 12B due toaxial movement of the collar 18 along the struts 12A, 12B.

The method 900 next moves to step 950 wherein the width of the implantis reduced or otherwise altered to reshape the mitral valve annulus. Instep 950, the width of the implant 1 may be altered due to decreasingthe angles between respective pairs of adjacent struts 12 from movementof respective collars 18 along the struts 12. The annulus may bereshaped due to the anchors 20 that secure the implant 1 to the tissue,thus bringing in the tissue with the reduced width implant 1.

The various features and functionalities may be combined in variousaspects. In one aspect, an implant such as a heart valve support ormitral valve annulus reconfiguration device may have a frame comprisinga plurality of struts, with adjacent pairs of struts joined orintegrally formed to form an apex which may point in an axial direction.The direction may be proximal and/or distal. A restraint such as acollar (or slider) may be advanced axially in a direction away from theapex (either proximally or distally) and over the struts, reducing theangle between struts at the apex and drawing or allowing the pair ofstruts to incline closer together. Movement of the collar towards theapex allows or causes an increase in the angle at the apex betweenadjacent struts and allows or causes the pair of struts to inclinefarther apart. For example, the struts may self-expand to increase theangle therebetween upon movement of the collar toward the apex, and/orthe collar may positively cause the struts to move apart to increasesuch angle. A shaft, including but not limited to the threaded shaftdescribed herein, having at least one radial engagement structure suchas a tab, a recess or a helical thread, has an axis of rotationextending in an axial direction. At least a first end and optionally asecond end of the shaft is rotatably connected to or with respect to theapex to permit rotation of the shaft with respect to the apex butprevent axial displacement of the shaft with respect to the apex. Thecollar is provided with a complementary engagement structure such as atleast one tab, recess or complimentary helical thread for rotatably orslidably engaging or otherwise engaging the engagement structure on theshaft such that rotation of the shaft produces axial displacement of thecollar.

In one implementation of this aspect, the collar has a first axiallyextending channel for receiving a first strut and a second axiallyextending channel for receiving a second strut. The collar may insteadhave a single axially extending opening or channel for receiving boththe first and second struts. The collar is also provided with a centralthreaded bore or other complementary features for engaging a threadedshaft carried by the apex. Rotation of the shaft drives the collaraxially along the pair of struts. A coupling or connector may beprovided for releasably coupling the shaft to a driver. The coupling maybe a proximally facing surface structure having an engagement surfacefor engaging a complementary engagement surface on the distal end of thedriver. Actuating the driver, for example rotating the driver, willtransmit rotation to the coupling and shaft and axial translation to thecollar, cinching or otherwise reducing the width of the implant, asdescribed.

FIGS. 47A-59 describe various embodiments of the implant 1, which mayinclude any of the features for the various implants described herein,such as the axially translatable collar 18 with rotatable shaft 646.Further, the implant 1 may include “reach” anchor features. These anchorfeatures may be used with any of the embodiments of the implantdescribed herein, including but not limited to the implants 1, 1A, 1B,1C, 100, 101, 102, 103, 104, 105, 500, 520, 520′, 530, which includesany embodiments of the implant 1 shown in and described with respect toFIGS. 38A-46, and vice versa.

FIG. 47A is a perspective view of the implant 1 having anchor assemblies20A at each distal apex 16. The implant 1 includes the frame 10 havingthe proximal end 2 and distal end 4. The proximal end 2 of the implant 1includes the shafts 646 with proximal couplings 660 and collars 18surrounding pairs of adjacent struts 12, as described. The distal end 4includes the anchor assemblies 20A each having an anchor housing 22A andan embodiment of the anchor 20 having a distal helical portion 26A witha proximal coupling 24D. The housing 22A is coupled with the distalapexes 16 and receives the anchors 20 therethrough. The collars 18 andanchors 20 are shown in a relative proximal position and may be adjustedproximally or distally therefrom to effect various changes in the frame10. The implant 1 of FIG. 47A and its various features are described infurther detail herein. The implant 1 of FIG. 47A may have any of thesame or similar features and/or functionalities as any other implantdescribed herein, including but not limited to the implant 1 of FIG.38A, and vice versa.

FIG. 47B is a perspective view of the implant 1 of FIG. 47A shown in aradially contracted configuration, for example a configuration suitablefor delivery through a delivery catheter. In FIG. 47B, the proximal end2 of the implant is shown without the cinching or contracting mechanismdescribed herein (threaded shaft 646, collar 18, etc.) for purposes ofillustration. The implant 1 may include the same or similar features asdescribed herein. For example the implant 1 includes the frame 10 withstruts 12 forming proximal apexes 14 and distal apexes 16, first andsecond proximal supports 630, 632 forming the window 634, medial flanges636, 638 forming the aperture 640, first and second projections 641, 643forming the gap 645, and the lower window 639. As described in furtherdetail above, the struts 12 may be joined at the proximal and distalapexes 14, 16 and the frame 10 may be formed of a metal alloy, such asan alloy of nickel titanium.

In FIG. 47B, the implant 1 supports a plurality of anchor assemblies20A. The implant 1 may have one or more of the anchor assemblies 20A. Asshown there are eight anchor assemblies 20A. There may be one, two,three, four, five, six, seven, nine, ten, eleven, twelve, or more anchorassemblies 20A. There may be one of the anchor assemblies 20A for eachdistal apex 16. The anchor assemblies 20A are coupled with, for exampleattached to, the distal end 4 of the implant 1, such as with thecorresponding distal apex 16.

The anchor assembly includes an anchor housing 22A and an anchor 20. Theanchor housing 22A is coupled with, for example attached to, the distalend 4 of the implant 1. As shown, the housing 22A is attached to theframe 10 at the distal apex 16. The housing 22A may be a separate partthat is attached to the frame 10, or the housing 22A maybe integral withthe frame 10, such as with the distal apex 16. The housings 22A arelocated primarily on a radially inward side of the distal apexes 16. Thehousing 22A may be located entirely on a radially inward side. Thehousings 22A extend from the apex 16 toward the central longitudinalaxis of the implant 1 (shown, for example, in FIG. 1). In someembodiments, the housings 22A may be located primarily or entirely onradially outer sides of the distal apexes 16.

FIG. 48 is a partial perspective view of a radially inward side of theimplant 1 of FIG. 47A. The implant 1 in FIG. 48 includes an embodimentof a cinching or contracting mechanism 30A. The mechanism 30A mayinclude any of the features described herein for any embodiment of theimplant 1. As shown in FIG. 48, the mechanism 30A includes the threadedshaft 646 retained between the first and second supports 632, 634 at theproximal apex 14, with the coupling 660 on a proximal end of the shaft646, and the collar 18 positioned at the proximal apex 14 andsurrounding the proximal ends of the pair of adjacent struts 12.Rotation of the shaft 646 causes the collar 18 to advance distally orproximally along the struts 12 to decrease or increase the angle betweenthe struts 12, as described herein.

An embodiment of a driver 40A is also depicted. The driver 40A is usedto engage with and drive, for example rotate, the shaft 646 by engagingthe coupling 660. The driver 40A may have the same or similar featuresand/or functionalities as any other drivers described herein, forexample the driver tubes 22′ shown in and described with respect to FIG.22D. There may be multiple drivers 40A. There may be one of the drivers40A for each of the shafts 646. The drivers 40A may be connected with arotational force transmitting member, such as a wire, that extendsthrough the delivery catheter and exits the patient at a proximal endfor manipulation by a surgeon.

FIG. 48 also depicts the implant 1 having one of the anchor assemblies20A. Other anchor assemblies 20A, which may be included, are not shownfor purposes of illustration. The anchor assemblies 20A are preferablymade of a suitable biocompatible metal alloy such as stainless steel,cobalt chromium, platinum iridium, or nickel titanium.

The anchor assembly 20A includes the anchor 20 having a distal helicalportion 26A and a proximal anchor head 24A. The anchor 20 includes aproximal coupling 24D at a proximal end of the anchor head 24A. Theanchor 20 is received within the anchor housing 22A. The anchor 20 isshown in a proximal position relative to the anchor housing 22A, suchthat a distal portion of the anchor 20 is located within the housing 22Ain the orientation shown. The anchor 20 may be advanced, for examplerotated, through the housing 22A to secure the helical portion 26A totissue. The anchor 20 may be driven by a corresponding driver thatengages the coupling 24D.

The helical portion 26A is connected to the proximal head 24. Eachhelical portion 26A is sharpened at its distal point 20B, or leadingturn, so as to facilitate penetration into the cardiac tissue. Eachhelical portion 26A is preferably seven to ten millimeters long in axiallength as measured along a central axis thereof. In some embodiments,the axial length of the helical portion 26A may be from about fivemillimeters to about fifteen millimeters, from about six millimeters toabout thirteen millimeters, or other ranges or lengths. The helicalportion 26A may be seven, eight, nine or ten millimeters long in axiallength. The helical portion 26A is capable of extending from about fourto about seven millimeters beyond the distal edge 16B of the distal apex16. In some embodiments, the helical portion 26A may be capable ofextending from about two to about nine millimeters beyond the distaledge 16B of the distal apex 16, or other ranges or distances. Thehelical portion 26A may be capable of extending four, five, six, orseven millimeters beyond the distal edge 16B of the distal apex 16.

The anchor assembly 20A includes the housing 22A facing radially inward.The housing 22A is coupled with the distal apex 16 at the window 16A. Anattachment 27A, as further described herein for example with respect toFIGS. 49A and 53A-53B, may attach to the distal apex 16 at the window16A. The window 16A may be a cutout of the distal apex 16. The window16A may therefore be an opening or space extending through the distalapex 16.

The housing 22A includes a proximal portion 22B and a distal portion22E. The proximal and distal portions 22B, 22E may include variousfeatures for engaging and/or guiding the anchor 20 to secure the anchor20 to tissue of the valve annulus. The proximal portion 22B includes aproximal end 20D. The distal portion 22E includes a distal end 20E. Theproximal and distal ends 20D, 20E may be used in the securement process.The proximal end 20D may provide a surface upon which a driver may bearwhile advancing the anchor 20. The distal end 20E may provide a surfacethat contacts the tissue. The distal end 20E may be located distally ofa distal edge 16B of the distal apex 16. The distal edge 16B is adistal-most end or surface of the distal end 4 of the frame 10. Thedistal edge 16B of the anchor housing 22A may be located even with orproximal to the distal edge 16B of the distal apex 16. Further detailsof the housing 22A are described herein, for example with respect toFIGS. 51-55.

FIGS. 49A and 49B are partial perspective views of the distal end 4 ofthe implant 1. FIG. 49A depicts one of the distal apexes 16. FIG. 49Bdepicts eight of the distal apexes 16 with only one anchor assembly 20A,for purposes of illustration.

As shown in FIG. 49A, the anchor housing 22A includes the attachment 27Athat engages with the window 16A of the distal apex 16. The attachment27A may include two sidewalls 27B, such as radial extensions of theanchor housing 22A, that form an interference or friction fit inside thewindow 16A for securement therein. The housing 22A may be attached tothe distal apex 16 using interference or friction fit, mechanicalattachments, welding, adhesives, other suitable means, or combinationsthereof. The housing 22A may be integral with the distal apex 16.

As shown in FIG. 49B, the implant 1 is inverted relative to theorientation in FIG. 49A. The anchor 20 is advanced in a relative distaldirection compared with FIG. 48.The coupling 24D is located adjacent theproximal end of the housing 22A. Portions of the anchor 20 locatedinside the housing 22a are shown in dotted line. Further details of theanchor assembly 20A are described herein, for example with respect toFIGS. 50A-55.

FIG. 50A depicts a side view of the anchor 20 having the distal helicalportion 26A and proximal head 24A. The helical portion 26A includes adistal portion 26C and a proximal portion 26B. The distal portion 26Cmay end at a tip 26D. The tip 26D may be a sharpened point configured topierce the cardiac tissue. The proximal head 24A extends from a distalend 24C to a proximal end 24B. The proximal head 24A may be solid orhollow. The head 24A may be formed from the same or similar materials asthe helical portion 26A. In some embodiments, the head 24A and helicalportion 26A may be different materials. The proximal head 24A may becylindrical in shape. In some embodiments, the proximal head 24A may bepartly cylindrical, rounded, segmented, other shapes, or combinationsthereof.

All or a portion of the proximal portion 26B of the helical portion 26Amay be coupled with the proximal head 24A. The helical portion 26A maybe wrapped around a distal end 24C of the proximal head 24A. The helicalportion 26A may be a separate portion attached to the proximal head 24A.The helical portion 26A may be received by a radially outer groove 24Eformed in the outer surface of the proximal head 24A. The groove 24E maybe partially or entirely helical in shape. The groove 24E may extendradially inward into the head 24A for a distance of about half thethickness of the extended member, for example wire, that forms thehelical portion 26A. The groove 24E may include a circumferential orannular portion as shown at or near a proximal end of the helicalportion 26A. In some embodiments, the helical portion 26A may bemechanically attached to the proximal head 24A, such as by interferenceor friction fit, with fasteners, adhesives, bands, other suitable means,or combinations thereof. In some embodiments, the helical portion 26Amay be integral with the proximal head 24A, for example formed from thesame monolithic piece of material.

The anchor head 24A includes a proximal end 24B having the coupling 24D.The coupling 24D may be integral with the proximal head 24A or aseparate part attached thereto. The coupling 24D may have the same orsimilar features and/or functionalities as other couplings describedherein, such as the coupling 660. As shown, the coupling 24D includes aproximal lateral projection 668A, a recess surface 670A, a distal base671A, and an opening 672A. These may be analogous to, respectively, thelateral projection 668, recess surface 670, a distal base 671, andopening 672 described with respect to the coupling 660. A correspondingdriver may engage and actuate, for example rotate, the coupling 660 todistally advance or proximally retract the anchor 20, as furtherdescribed herein, for example with respect to FIG. 54.

FIG. 50B is a detail side view of the anchor assembly 20 showing aninterface between the anchor housing 22A and the anchor 20. The proximalhead 24A and helical portion 26A are received into the housing 22A. Theentire helical portion 26A may be advanced distally of the proximal end20E of the housing 22A. The proximal head 24A may be advanced distallyof the proximal end 20E of the housing 22A.

FIG. 51 is a partial cross-section view of the anchor assembly 20A. Onlypart of the helical portion 26A of the anchor 20 is shown for purposesof illustration. The helical portion 26A appears as separate parts dueto the cross-section view. An axis of rotation is indicated. The anchor20 may be rotated about the axis to proximally or distally advance theanchor 20 relative to the housing 22A.

The housing 22A includes a lumen or opening 20B extending through thehousing 22A. The opening 20B is a space axially extending along the axisof rotation through the housing 22A. The opening 20B provides a spacethrough which the anchor 20 may be advanced. The opening 20B extendsthrough the proximal portion 22B of the housing 22A. The proximalportion 22B of the opening 20B includes a groove 22D configured to guidethe helical portion 26A therealong. The groove 22D may be an internalthread of the proximal portion 22B. The helical portion 26A is receivedpartially into the groove 22D and prevents axial translation of theanchor 20 until the anchor 20 is rotated so that the helical portion 26Acan slide circumferentially along the groove 22D. The groove 22D mayhave a corresponding helical shape and extend from a proximal end of theproximal portion 22B, such as from the proximal end 20E, to a distal endof the proximal portion 22B.

The housing 22A includes a proximal inner surface 22C located at theproximal portion 22B. The inner surface 22C defines a width, for examplediameter, of a region of the opening 20B that extends through theproximal portion 22B. The inner surface 22C is located radially inwardrelative to an outer diameter of the groove 22D. The inner surface 22Cmay be defined by a proximal sidewall of the housing 22A thatcircumferentially surrounds the proximal region of the opening 22B andextends axially.

The housing 22A includes a distal portion 22E located distally of theproximal portion 22B. The opening 20B extends through the distal portion22E to form a chamber. The distal portion 22E includes a distal innersurface 22F. The inner surface 22F defines a width, for examplediameter, of a region of the opening 20B that extends through the distalportion 22E. The width of the opening 20B at the distal portion 22E isgreater than a width of the opening 20B at the proximal portion 22B. Forexample, the diameter of the distal inner surface 22F is greater thanthe diameter of the proximal inner surface 22C. The distal inner surface22F may have a width that is the same or greater than the outer radialdimension of the groove 22D of the proximal portion 22B. The innersurface 22F may be defined by a distal sidewall of the housing 22A thatcircumferentially surrounds the distal region of the opening 22B andextends axially. The inner surface 22F may be smooth, for example it maynot include grooves or threads.

The anchor 20 may be introduced into the housing 22A by engaging the tip26D of the helical portion 26A with the groove 22D and then rotating theanchor 20 through the proximal portion 22B of the housing 22A. As theanchor 20 is rotated, the helical portion 26A mechanically communicateswith, for example slides through, the groove 22D to advance the anchor20. Rotation of the anchor 20 in a first rotation direction will causeaxial advancement of the anchor 20 in a first axial direction (forexample distally), and rotation of the anchor 20 in a second rotationdirection that is opposite the first rotation direction will cause axialadvancement of the anchor 20 in a second axial direction (for exampleproximally) that is opposite the first axial direction.

In the configuration shown in FIG. 51, the helical portion 26A of theanchor 20 is engaged with the inner groove 22D of the housing 22A andextends into the distal portion 22E and exits the distal end of thehousing 22A. The head 24A of the anchor extends out the proximal end ofthe housing 22A. The anchor 20 may be further rotated to advance theanchor 20 distally such that the helical portion 26A advances distallyand entirely exits the proximal portion 22B. The helical portion 26A maythen be located inside the distal portion 22E, for example as shown inFIG. 52.

FIG. 52 depicts the anchor 20 in a distal position relative to theconfiguration shown in FIG. 51. As shown in FIG. 52, the helical portion26A is located entirely within the distal portion 22E and outside thedistal end of the housing 22A. The helical portion 26A has thus exitedthe groove 22D. Further rotation of the anchor 20 in this position willcause the anchor 20 to rotate while maintaining the axial position ofthe anchor 20. The anchor 20 will thus not advance farther distally dueto rotation alone. The anchor 20 may therefore “freely spin” in thisposition. If desired, the anchor 20 may be pushed farther distally, forexample with the driver. In some embodiments, the anchor 20 is preventedfrom farther distal advance relative to the position shown in FIG. 52,for example with use of a flange 24F at the head 24A of the anchor 20.The flange 24F may bear against the distal end 20E of the housing 22A,as shown in FIG. 52. In some embodiments, there may not be the flange24F. In some embodiments, as further described herein, distal advance ofthe anchor 20 may be limited due to engagement with a coupling of adriver that rotates the anchor 20. In some embodiments, such driver maybe incorporated with the flange 24F such that the flange 24F will limitdistal axial advance of the anchor 20 after removal of the driver fromthe anchor 20. Further details of a driver and coupling are describedherein, for example with respect to FIGS. 54 and 57-58.

The anchor 20 may engage tissue while the anchor 20 is “freely spinning”as described. Thus, the anchor 20 may distally advance into tissue whilerotating within the distal portion 22E of the housing 22A. The housing22A may also advance distally with the anchor 20. The housing 22A mayadvance distally due to distal force from a driver used to rotate theanchor 20, as described. The housing 22A may advance distally due todistal force from the flange 24F of the anchor 20 as the anchor advancesdistally into tissue due to rotation of the anchor 20 into the tissue.Thus, the anchor 20 and the housing 22A may advance distally togethersuch that the anchor 20 and the housing 22A maintain a relativelyconstant axial position with each other. As the anchor 20 engagestissue, the housing 22A will advance distally toward the tissue. Thedistal end 20D of the housing 22A may contact the tissue. In someembodiments, the distal end 22D may be drawn toward the tissue withengagement of the anchor 20 and tissue, as described. In someembodiments, the implant 1 may initially be positioned with the distalend 22D of the anchor housing 22A contacting the tissue, and the anchor20 may then be rotated through the housing 22A as described. Afteradvance of the helical portion 26A into tissue, any remaining gap orspace between the tissue and the housing 22A may be closed by using the“free spin” techniques described herein, for example further rotation ofthe anchor 20 while the helical portion 26A is located within the distalportion 22E of the housing 22A. The distal end 20D of the housing 22Amay be flat or generally flat, for example planar and perpendicular tothe longitudinal axis, or it may be contoured, for example curved.

FIGS. 53A and 53B are respectively proximal end and perspective views ofthe housing 22A. The housing 22A includes a body 20C. The body 20C mayinclude the opening 20B therethrough and receive the anchor 20 therein.The body 20C may be rounded, for example cylindrical as shown, or othershapes or profiles. The body 20C may have a substantially uniform outerwidth, for example diameter, while the internal opening 20B may havevaried widths, as described. The body 20C adjacent the proximal end 20Dmay include a pocket 25A. The pocket 25A may be a recess in the proximalportion 22B of the housing 22A. Also, the pocket 25A is shown as havinga somewhat square profile for receiving the anchor head 24, but it mayhave other shapes such as a somewhat star-shaped profile or others. Thiswould facilitate the anchor head 24 seating with the pocket 25A.Furthermore, internal threading of the proximal portion 22B, such as thegroove 22D, of the anchor housing 22A may terminate distally of thepocket 25A or extend up into the pocket 25A.

The pocket 25A may include a proximally-facing shelf 25D surrounded byone or more rounded side surfaces 25B and one or more straight sidesurfaces 25C. The side surfaces 25B, 25c may be shaped to complement theside contour if the anchor head 24A such that the anchor head 24A isprevented from rotating therein. The pocket 25A may receive a portion ofthe anchor head 24A therein and rotationally and/or axially lock theanchor 20 therein. A distal facing surface of the anchor 20, such as adistal facing surface of the flange 24F, may contact the shelf 25D toprevent farther distal advance of the anchor 20. The anchor 20 maycontact and rest on the shelf 25D after engagement of the anchor 20 withtissue and removal of the anchor driver.

The housing 22A may include an attachment 27A. The attachment 27A may belocated to a lateral side of the body 20C. The attachment 27A mayinclude one or more sidewalls 27B extending laterally from the body 20C.The sidewalls 27B may extend laterally and outwardly to form an angletherebetween. The sidewalls 27b may open outwardly and flex inwardly tofacilitate attachment with the frame 10. The attachment 27A may includean end wall 27C. The end wall 27C may connect laterally outward ends ofthe sidewalls 27B as shown. The end wall 27C may provide stiffness tothe sidewalls 27B. The 27C may also flex to facilitate engagement of thesidewalls 27B with the frame 10. An opening 27D may extend through theattachment 27A and be defined by the sidewalls 27B and end wall 27D. Theopening 27D may reduce the weight of the housing 22A. The sidewalls 27Emay include a window 27E. The window 27E may receive corresponding tabslocated on circumferentially inner sides of the window 16A of the distalapex 16. In some embodiments, the opening 27D may receive a portion ofthe frame 10 of the implant 1 therein. For example, the distal apex 16may be received into the opening 27D for attachment of the housing 22Awith the frame 10. The window 27E may receive therein correspondingcircumferentially outer tabs of the distal apex 16. Thus, the anchorhousing 22A may be attached with the frame 10 using a variety oftechniques.

FIG. 54 is a partial cross-section view of the anchor assembly 20Ashowing the anchor housing 22A having the anchor 20 therein engaged witha driver 42. The driver 42 may extend through and exit the distal end ofa driver tube 42A (see FIG. 57). The driver 42 may be rotated totransmit rotation forces to the anchor 20. The driver 42 includes acover 43 surrounding a latch 44. A distal end 43A of the cover 43 maycontact the proximal end 20D of the housing 22A. The driver 42 may be inthis position while the implant 1 is being delivered through thedelivery catheter. The latch 44 includes a coupling portion 45 thatcouples with the coupling 24D of the anchor head 24A. The couplingportion 45 as shown may include a lateral projection 46, a recesssurface 47, a base 48, and an opening 49. These features of the driver42 may be analogous to, respectively, the lateral projection 668A, therecess surface 670A, the base 671A, and the opening 672A of the anchorcoupling 24D.

The lateral projection 46 of the driver coupling portion 45 may bereceived into the opening 672A of the anchor head 24A. The lateralprojection 668A of the anchor head 24A may be received into the opening49 of the driver coupling portion 45. The corresponding recess surfaces670A and 47 may contact each other and prevent relative axial movementas well as lateral movement along a lateral axis. “Lateral” as used hereindicates a direction that is perpendicular or generally perpendicularto the axis of the anchor 20 and/or driver 42. The cover 43 may surroundthe coupled connection between the two couplings 24D and 45 to preventrelative lateral slippage of the couplings 24D and 45. The driver 42 maythen be rotated, for example by a surgeon rotating a proximal end of thedriver 42, to transmit rotation to the anchor 20 via the anchor coupling24D. This rotation will cause the anchor head 24A and helical portion26A to rotate, and the anchor 20 can then advance distally as described.Rotation may be applied to the driver in an opposite direction toadvance the anchor 20 proximally as described.

As shown in FIG. 55, the anchor assembly 20A includes the anchor 20advanced distally into and through the anchor housing 22A relative tothe position shown in FIG. 54 and the driver 42 has been removed. Theposition shown in FIG. 55 may be the final securement position of theanchor 20. The coupling 24D is protruding proximally out of the opening20B of the housing 22A. The coupling 24D may protrude proximally of theproximal end 20D of the housing 22A.

The driver 42 has been removed as shown in FIG. 55. The driver 42 may beremoved by retracting the anchor 20 in the proximal direction to exposethe coupling connection with the anchor 20, as is further described withrespect to FIGS. 56-59. In some embodiments, the cover 43 may beretractable proximally while maintaining the axial position of thecoupling connection of the driver 42 and anchor 20.

Further, when the helical portions 26A are rotationally driven into theheart valve annulus tissue and the implant 1 is forcibly reduced inwidth reducing the size of the valve annulus, a tensile force isdeveloped on and stored in the anchor assembly 20A. This tensile forcewill tend to draw the anchor head 24A toward pocket 25A of the housing22A. As shown in FIG. 54, the latch 44 of the driver 42 produces acounter tension and keeps the anchor head 24A from being pulled into thepocket 25A. When the driver 42 and latch 44 are disengaged from theanchor head 24, some of the tensile force stored in the anchor assembly20A is released. The anchor head 24A is then pulled into the lock pocket25A, as shown in FIG. 55. In this manner, the anchor head 24A, andanchor helical portion 26A, are rotationally constrained. This resultsin somewhat of a self-locking feature of the anchor assembly 20A. Morespecifically, owing to the potential energy stored in the anchorassembly 20A as a consequence of the anchoring and cinching of theimplant 1, once the driver 42 is disengaged from the anchor 20, some ofthat stored energy is released causing the anchor head 24A to be pulled,or dropped, into the pocket 25A. These and other steps of anchoring andlocking the anchor assembly 20A are described, more particularly, withreference to FIG. 56-59.

FIGS. 56-59 are partial perspective views depicting sequentialpositioning of the anchor 20 with the driver 42, engagement of tissuewith the anchor 20, de-coupling of the driver 42 form the anchor 20, andsettling in of the anchor 20 with the housing 22A. FIG. 56 shows theanchor 20 in a relative proximal position relative to the housing 22A.The anchor 20 may be in this position during delivery and prior tosecuring the implant 1 to tissue. The driver 42, not shown for claritypurposes, may be engaged with the anchor 20 in this position. Thehelical portion 26A may be engaged with the proximal portion 22B of thehousing 22A, as described. The helical portion 26A may or may not belocated partially within the distal portion 22E of the housing 22A. Thehelical portion 26A may not extend past the distal end 20E of thehousing 22A in this position. The driver 42 may be engaged with and beused to rotate the anchor 20, as described, to distally advance theanchor 20 to the positon shown in FIG. 57.

As shown in FIG. 57, the driver 42 extends through the driver tube 42Aand is located distally of and adjacent to the housing 22A. The driver42 may contact the proximal end 20D of the housing 22A. The driver 42may provide an axial distal force to the anchor assembly 20A whilerotating the anchor 20. Thus, the anchor housing 22A may advancedistally due to force from the driver 42. The driver 42 may bear againstthe proximal end 20D. The driver 42 may rotate the anchor 20 to “freelyspin” the anchor 20 as described. The helical portion 26A of the anchor20 may be inside the distal portion 22E of the housing 22A such that theanchor can rotate 20 while maintaining an axial position relative to thehousing 22A. The helical portion 26A may engage tissue and advancedistally into the tissue while the anchor housing 22A, and thus at leastthe corresponding portion of the frame 10 to which the housing 22A isattached, moves distally toward the region of tissue into which thehelical portion 26A of the anchor 20 is engaging. The anchor 20 may berotated until the distal end 20E of the housing 22A has contacted or iswithin a sufficient distance of the tissue. A “sufficient” distanceincludes distances such that contraction of the implant 1, byadvancement of the collar 18, will reduce or eliminate regurgitation ofthe blood through the valve.

In some embodiments, the anchor assembly 20A has the configuration shownin FIG. 57 after the anchor 20 has reached its final distal position.Some, most, or all of the helical portion 26A may be engaged with thetissue in the final position. In some embodiments, the anchor 20 may bein the final position with the helical portion 26A still partly engagedwith the proximal portion 22B of the anchor housing 22A, such as thegroove 22D, as described. For example, the housing 22A may contacttissue before the helical portion 26A advances distally beyond thedistal end 20E of the housing 22A. The anchor 20 may then be rotated,and the helical portion 26A may or may not be engaged with the proximalportion 22B of the housing 22a in its final position. In someembodiments, the anchor housing 22A contacts the tissue, the anchor 20is then rotated and advanced distally into tissue, and the anchor 20“freely spins” in the distal portion of the housing 22A, as described,in order to remove any gap between the housing 22A and tissue orotherwise ensure a sufficiently small distance therebetween.

FIG. 58 depicts the driver 42 being disengaged from the anchor head 24.The driver 42 is first withdrawn slightly exposing its distal latch 44which is mated with the anchor head 24. The coupling portion 45 of thedriver 42 may be moved laterally to disengage from the coupling 24D ofthe anchor 20. The coupling portion 45 may be moved directly away fromthe coupling 24D (for example to the right as oriented in the figure) orslid along the coupling 24D (for example into or out of the plane of thefigure as oriented). Once disengaged, the anchor head 24 drops into andself-locks into the anchor housing 22A, as shown in FIG. 59. FIG. 59depicts the anchor 20 in its fully deployed and locked state, with thedriver 42 disengaged from the anchor head 24.

The implant 1 may be repositioned and, if necessary, retrieved from thepatient after implantation. For example, the collars 18 may be adjustedto further contract or expand the implant 1. The shafts 646 may berotated in opposite directions to cause the collars 18 to advanceproximally or distally as desired. The anchors 20 may be rotated inopposite directions to cause proximal or distal advance of the anchors20.

In particular, to reposition the implant 1, the shafts 646 may berotated to advance the collars proximally or distally to obtain thedesired shape of the frame 10 and thus of the annulus. Some collar 18may be advanced farther distally than other collars 18 to allow fordifferent angles between different pairs of adjacent struts 12. Some ofthe angles C (see FIG. 44C) may be larger or smaller than other of theangles C as desired.

The implant 1 may be removed from securement with tissue if needed. Theanchors 20 may be secured to tissue and then removed from engagementwith the tissue by rotation in the opposite direction. The anchors 20may be retracted via the “free spin” technique described herein, wherethe housing 22A also moves distally with the anchors 20. The anchors 20may be retracted into the housing 22A so that the helical portion 26Aengages the proximal grooved portion 22B of the housing 22A. The anchors20 may be retracted back to a same starting position as prior todelivery. Prior to retraction of the anchors 20 from tissue, the collars18 may be advanced proximally or distally to facilitate anchor 20removal. For example, the collars 18 may be advanced proximally toremove contraction stresses on the frame 10 which may assist withremoval of the anchors 20, such as by removing circumferential forces onthe anchors 20 from the frame 10.

The implant 1 may be retrieved by proximal retraction of the anchors 20from tissue engagement as described and proximal advance of the collars18 as described. The anchors 20 may be disengaged from the tissue andproximally retracted some, most or all of the possible retractiondistance, such as back to their starting position. The collars 18 may beadvanced proximally some, most, or all of the possible proximallydistance, such as back to their starting position at the proximal apex14. In some embodiments, after removal of the anchors 20 from engagementwith tissue, one or more collars 18 may be advanced distally to contractthe implant 1 to a retrieval configuration. The collars 18 may beadvanced distally to reduce the angle C between pairs of adjacent struts12 such that the implant 1 reduces in overall width and can bere-sheathed for removal with the delivery catheter.

In some embodiments, after implantation of various implants describedherein, such as implant 1, the heart valve annulus may remodel. Thusdynamic post implantation constriction of the annulus may be achieved.The annulus may remodel due to residual stresses in the annulus impartedby the contracted and stressed implant 1 acting on the annulus. Theinward forces imparted on the annulus by the contracted implant 1 maythus cause the tissue to remodel and further contract. The implant 1 maycause such remodeling due to the structure of the implant 1. Forexample, the reduction of the angle C between every pair of adjacentstruts 12 will impart an inward force on the annulus at every distalapex 16. The uniform distribution of these inward forces at each anchor20 about the annulus may cause it to remodel and further contract withthe passage of time. Thus, the implant 1 may be used to further reduceregurgitation after a period of time post implantation of the implant 1.In some embodiments, the annulus may reduce in width after implantationof the implant 1 from about 0.5 millimeters to about 3 millimeters, fromabout 1 millimeter to about 2 millimeters, or other ranges or amounts.In some embodiments, the annulus may reduce in width after implantationof the implant 1 from about 1% to about 15%, from about 2% to about 10%,from about 5% to about 8%, or other ranges or percentages. Thispercentage may be a percentage of the annulus width after implantationand removal of the adjustment catheter or driver. The annulus maycontinue to reduce in width for a period of time after implantation ofthe implant 1 of about 2 days to about 30 days, of about 3 days to about20 days, of about 4 days to about 15 days, of about 5 days to about 10days, or other ranges or periods of time. The implant 1 may reduce inwidth post-implantation a corresponding amount and time as describedherein with respect to the annulus post-implantation reduction in width.

The implant 1 may thus be used for dynamic post implantationconstriction of the annulus surrounding a heart valve. In someembodiments, the implant 1 may have a moveable restraint such as thecollar 18, that may be at least partially surrounding the pair ofadjacent struts 12 and can be moved along the pair of adjacent struts 12away from the apex to reduce the angle C between the pair of adjacentstruts 12. This may cause the implant body such as the frame 10 tocontract the annulus from a first diameter to a second, smallerdiameter, with at least one strut 12 initially elastically deflected byresistance to movement imposed by the annulus when in the seconddiameter. The struts 12 may be under a bending moment and storepotential mechanical energy due to the bending. The bending may be in orout of plane bending. The implant 1 may be configured to contract postimplantation from the second diameter to a third, smaller diameter aselastic tension in the strut 12 relaxes and overcomes resistance tomovement imposed by the annulus. In some embodiments, the elastictension, for example elastic energy due to bending, is stored in thestruts 12 in between the movable restraint 18 and tissue anchor 20. Thisenergy may be released or partially released as the annulus remodels andfurther constricts post implantation of the implant 1. One, some or allof the struts 12 may contribute to the remodeling as described.

Various methods for dynamic post implantation constriction of an annulussurrounding a heart valve may be performed with the various implantsdescribed herein. The method may comprise the steps of securing theimplant 1 to the wall of the atrium surrounding a mitral valve annulushaving a first diameter. The implant 1 may be actively adjusted with anadjustment catheter to reduce the annulus from the first diameter to asecond, smaller diameter. The adjustment catheter may be removed. Thediameter may continue to be reduced to a third diameter that is smallerthan the second diameter following removal of the catheter, in responseto potential energy stored in the implant 1.

Various sizes and dimensions for dynamic post implantation constrictionof the annulus may be achieved. For example, the second diameter may beno more than about 27 mm and the third diameter may be at least 1 mmsmaller than the second diameter. The second diameter may be no morethan about 27 mm and the third diameter may be at least 2 mm smallerthan the second diameter. The implant 1 may be configured to contractpost implantation from the second diameter to the third, smallerdiameter within about 30 days after removing the adjustment catheter.Further, mitral leaflet coaptation may increase by at least about 25% inresponse to reduction of the annulus from the second diameter to thethird diameter. Mitral leaflet coaptation may increase by at least about50% in response to reduction of the annulus from the second diameter tothe third diameter. The diameter may continue to reduce for at leastabout five days following removing the adjustment catheter. The diametermay continue to reduce for at least about 10 days following the removingthe adjustment catheter.

In some embodiments, following removing the catheter, the dynamicimplant 1 increases leaflet coaptation by at least about 25% from thecoaptation corresponding to the second diameter. In some embodiments,following removing the catheter, the dynamic implant 1 increases leafletcoaptation by at least about 50% from the coaptation corresponding tothe second diameter. In some embodiments, following removing thecatheter, the dynamic implant increases leaflet coaptation by at leastabout 2 mm. In some embodiments, following removing the catheter, thedynamic implant 1 increases leaflet coaptation by at least about 4 mm.

Various modifications to the implementations described in thisdisclosure will be readily apparent to those skilled in the art, and thegeneric principles defined herein can be applied to otherimplementations without departing from the spirit or scope of thisdisclosure. Thus, the disclosure is not intended to be limited to theimplementations shown herein, but is to be accorded the widest scopeconsistent with the claims, the principles and the novel featuresdisclosed herein. The word “example” is used exclusively herein to mean“serving as an example, instance, or illustration.” Any implementationdescribed herein as “example” is not necessarily to be construed aspreferred or advantageous over other implementations, unless otherwisestated.

Certain features that are described in this specification in the contextof separate implementations also can be implemented in combination in asingle implementation. Conversely, various features that are describedin the context of a single implementation also can be implemented inmultiple implementations separately or in any suitable sub-combination.Moreover, although features can be described above as acting in certaincombinations and even initially claimed as such, one or more featuresfrom a claimed combination can in some cases be excised from thecombination, and the claimed combination can be directed to asub-combination or variation of a sub-combination.

Similarly, while operations are depicted in the drawings in a particularorder, this should not be understood as requiring that such operationsbe performed in the particular order shown or in sequential order, orthat all illustrated operations be performed, to achieve desirableresults. Additionally, other implementations are within the scope of thefollowing claims. In some cases, the actions recited in the claims canbe performed in a different order and still achieve desirable results.

It will be understood by those within the art that, in general, termsused herein are generally intended as “open” terms (e.g., the term“including” should be interpreted as “including but not limited to,” theterm “having” should be interpreted as “having at least,” the term“includes” should be interpreted as “includes but is not limited to,”etc.). It will be further understood by those within the art that if aspecific number of an introduced claim recitation is intended, such anintent will be explicitly recited in the claim, and in the absence ofsuch recitation no such intent is present. For example, as an aid tounderstanding, the following appended claims may contain usage of theintroductory phrases “at least one” and “one or more” to introduce claimrecitations. However, the use of such phrases should not be construed toimply that the introduction of a claim recitation by the indefinitearticles “a” or “an” limits any particular claim containing suchintroduced claim recitation to embodiments containing only one suchrecitation, even when the same claim includes the introductory phrases“one or more” or “at least one” and indefinite articles such as “a” or“an” (e.g., “a” and/or “an” should typically be interpreted to mean “atleast one” or “one or more”); the same holds true for the use ofdefinite articles used to introduce claim recitations. In addition, evenif a specific number of an introduced claim recitation is explicitlyrecited, those skilled in the art will recognize that such recitationshould typically be interpreted to mean at least the recited number(e.g., the bare recitation of “two recitations,” without othermodifiers, typically means at least two recitations, or two or morerecitations). Furthermore, in those instances where a conventionanalogous to “at least one of A, B, and C, etc.” is used, in generalsuch a construction is intended in the sense one having skill in the artwould understand the convention (e.g., “a system having at least one ofA, B, and C” would include but not be limited to systems that have Aalone, B alone, C alone, A and B together, A and C together, B and Ctogether, and/or A, B, and C together, etc.). In those instances where aconvention analogous to “at least one of A, B, or C, etc.” is used, ingeneral such a construction is intended in the sense one having skill inthe art would understand the convention (e.g., “a system having at leastone of A, B, or C” would include but not be limited to systems that haveA alone, B alone, C alone, A and B together, A and C together, B and Ctogether, and/or A, B, and C together, etc.). It will be furtherunderstood by those within the art that virtually any disjunctive wordand/or phrase presenting two or more alternative terms, whether in thedescription, claims, or drawings, should be understood to contemplatethe possibilities of including one of the terms, either of the terms, orboth terms. For example, the phrase “A or B” will be understood toinclude the possibilities of “A” or “B” or “A and B.”

What is claimed is:
 1. An implant for reshaping a mitral valve annulus,the implant comprising: a frame having a proximal end, a distal end anda central lumen extending therethrough; and an anchor carried by theframe and axially moveable between a first position and a secondposition, wherein in the first position the anchor advances axiallyrelative to the frame in response to rotation of the anchor in a firstdirection, and in the second position the anchor is freely rotatable inthe first direction without causing axial advance relative to the frame.2. The implant of claim 1 wherein the frame is comprised of a pluralityof struts, at least two of the plurality of struts are joined at adistal apex, and wherein the anchor is carried by the distal apex. 3.The implant of claim 2 wherein the distal apex includes an anchorhousing configured to rotatably receive the anchor therethrough.
 4. Theimplant of claim 3 wherein the anchor comprises a proximal couplingportion and a helical coil portion.
 5. The implant of claim 4 whereinthe anchor housing includes an opening extending axially therethrough,and the anchor is configured to engage tissue of the mitral valveannulus in the second position by rotating within the anchor housingwhile maintaining an axial position relative to the anchor housing. 6.The implant of claim 5 wherein the opening of the anchor housingcomprises a proximal portion and a distal portion, the proximal portioncomprising a groove to guide the helical coil portion of the anchorthere along.
 7. The implant of claim 6 wherein the groove inhibits axialtranslation of the anchor through the anchor housing.
 8. The implant ofclaim 6 wherein the proximal portion of the opening comprises a proximalinner surface that defines a proximal housing diameter, wherein theproximal inner surface extends radially inward relative to an outerdiameter of the groove.
 9. The implant of claim 8 wherein the distalportion of the opening comprises a distal inner surface that defines adistal housing diameter, and wherein the distal housing diameter isgreater than the outer diameter of the groove.
 10. The implant of claim9 wherein the distal housing diameter is greater than a diameter of thehelical coil portion of the anchor
 11. The implant of claim 10 whereinthe distal inner surface of the anchor housing is smooth.
 12. Theimplant of claim 11 wherein the second position comprises a positionwherein the helical coil portion of the anchor is fully within thedistal portion of the anchor housing.
 13. An implant comprising: atubular frame having a proximal end, a distal end and a central lumenextending therethrough, the tubular frame comprising a plurality ofpairs of struts joined to form a plurality of proximal apices and aplurality of distal apices; an adjustment mechanisms coupled to a firstpair of struts that form a proximal apex, the adjustment mechanismconfigured to control a spacing between distal ends of the first pair ofstruts; an anchor housing carried by a distal apex formed by a secondpair of struts; an anchor translationally disposed within an opening ofthe anchor housing and axially moveable between a first position and asecond position, wherein in the first position the anchor advancesaxially relative to the tubular frame in response to rotation of theanchor in a first direction, and in the second position the anchor isfreely rotatable in the first direction without causing axial advancerelative to the tubular frame.
 14. The implant of claim 13 wherein theanchor comprises a proximal coupling portion and a helical coil portion.15. The implant of claim 14 wherein the opening of the anchor housingcomprises a proximal portion and a distal portion, the proximal portioncomprising a groove to guide the helical coil portion of the anchorthere along and to inhibit axial translation of the anchor through theanchor housing.
 16. The implant of claim 15 wherein the proximal portionof the opening comprises a proximal inner surface that defines aproximal housing diameter, wherein the proximal inner surface extendsradially inward relative to an outer diameter of the groove.
 17. Theimplant of claim 16 wherein the distal portion of the opening comprisesa distal inner surface that is smooth and that defines a distal housingdiameter, and wherein the distal housing diameter is greater than theouter diameter of the groove.
 18. The implant of claim 17 wherein thedistal housing diameter is greater than a diameter of the helical coilportion of the anchor.
 19. The implant of claim 11 wherein the secondposition comprises a position wherein the helical coil portion of theanchor is fully within the distal portion of the anchor housing.
 20. Amethod of anchoring an implant to patient tissue proximate to a valveannulus includes the steps of: transluminally advancing the implanttowards the valve annulus, the implant comprising: an expandable framehaving a proximal end, a distal end and a central lumen extendingtherethrough; an anchor housing carried by the distal end of theexpandable frame, the anchor housing comprising an opening extendingtherethrough, the opening comprising a proximal grooved inner surfaceportion having a grooved portion diameter and a distal smooth innersurface portion having a distal housing diameter that exceeds thegrooved portion diameter; an anchor axially disposed within the anchorhousing, the anchor comprising a proximal coupler portion and a helicalcoil portion; expanding the implant to an annulus engagement diameter;rotating the anchor to engage the helical coil portion of the anchorwith the proximal grooved inner surface portion of the anchor housing toaxially translate the anchor through the anchor housing and into tissuearound the valve annulus; and rotating the anchor when the helical coilportion of the anchor is fully within the distal smooth inner surfaceportion of the anchor housing to pull together the anchor housing andthe tissue around the valve annulus.